2 Jobs für Marketing in Regensdorf
GRA CMC Director - Marketed Products Development Lead
Zürich, Zürich
Takeda Pharmaceuticals
Vor 4 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
**Job Description - Director GRA CMC Marketed Products Development (MPD) Lead**
Join Takeda as Director, Global Regulatory Affairs CMC Marketed Products Development (MPD) Lead, where you are accountable for developing and executing on GRA CMC strategies for lifecycle management. You develop and execute on global strategies across the existing portfolio, lead a team, and ensure their effectiveness in a complex matrix environment. Reporting to the Head of GRA CMC for MPD, CMC Sourcing and Due Diligence, you partner closely across the organization to influence, enhance prioritization, and strengthen communication and decision making processes.
**How you will contribute:**
+ Independently manage regulatory submissions for assigned compounds for global marketing applications, and post-approval life cycle activities.
+ Evaluate change proposals for global regulatory impact and plan global variations and amendments.
+ Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
+ Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and review content for conformance with established requirement.
+ Ensures project team, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Provide solutions to prevent recurrence of issues.
+ Interact directly with international Health Authorities. Participate in and facilitate agency meetings.
+ Stay up to date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share experience with others to support their development.
+ Maintain constructive relations with essential colleagues, e.g., colleagues within Takeda, Alliance Partners, and Health Authority representatives.
**What you bring to Takeda:**
+ BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
+ 10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
+ Experience with active pharmaceutical ingredient/drug substances, drug products, biologics, analytical characterization, process scale-up or regulatory registration of products is required.
+ Expert in developing alternate strategies based on guidance/regulations.
+ Expert in liaising with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings. International experience preferred.
+ Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support; application of knowledge to all areas of life-cycle management.
+ Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
+ Able to provide sound strategic advice and enable critical decisions under ambiguity.
+ Demonstrate leadership, problem-solving ability, flexibility, and values teamwork.
+ Demonstrate strategic enterprise thinking, with the ability to influence at all levels in a complex matrix environment.
+ Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
+ Good judgement in elevating and communicating actual or potential issues to line management.
+ Builds and maintains a team environment that inspires and enables people to move the organization forward.
+ Expert in CTD authoring and/or review skills throughout the product lifecycle, with a solid understanding of global submission complexities.
**Travel Requirements:**
+ Willingness to travel to various meetings, including overnight trips.
+ Requires approximately up to 10-30% travel.
**Locations**
Zurich, Switzerland
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Description**
**Job Description - Director GRA CMC Marketed Products Development (MPD) Lead**
Join Takeda as Director, Global Regulatory Affairs CMC Marketed Products Development (MPD) Lead, where you are accountable for developing and executing on GRA CMC strategies for lifecycle management. You develop and execute on global strategies across the existing portfolio, lead a team, and ensure their effectiveness in a complex matrix environment. Reporting to the Head of GRA CMC for MPD, CMC Sourcing and Due Diligence, you partner closely across the organization to influence, enhance prioritization, and strengthen communication and decision making processes.
**How you will contribute:**
+ Independently manage regulatory submissions for assigned compounds for global marketing applications, and post-approval life cycle activities.
+ Evaluate change proposals for global regulatory impact and plan global variations and amendments.
+ Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
+ Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and review content for conformance with established requirement.
+ Ensures project team, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Provide solutions to prevent recurrence of issues.
+ Interact directly with international Health Authorities. Participate in and facilitate agency meetings.
+ Stay up to date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share experience with others to support their development.
+ Maintain constructive relations with essential colleagues, e.g., colleagues within Takeda, Alliance Partners, and Health Authority representatives.
**What you bring to Takeda:**
+ BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
+ 10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
+ Experience with active pharmaceutical ingredient/drug substances, drug products, biologics, analytical characterization, process scale-up or regulatory registration of products is required.
+ Expert in developing alternate strategies based on guidance/regulations.
+ Expert in liaising with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings. International experience preferred.
+ Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support; application of knowledge to all areas of life-cycle management.
+ Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
+ Able to provide sound strategic advice and enable critical decisions under ambiguity.
+ Demonstrate leadership, problem-solving ability, flexibility, and values teamwork.
+ Demonstrate strategic enterprise thinking, with the ability to influence at all levels in a complex matrix environment.
+ Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
+ Good judgement in elevating and communicating actual or potential issues to line management.
+ Builds and maintains a team environment that inspires and enables people to move the organization forward.
+ Expert in CTD authoring and/or review skills throughout the product lifecycle, with a solid understanding of global submission complexities.
**Travel Requirements:**
+ Willingness to travel to various meetings, including overnight trips.
+ Requires approximately up to 10-30% travel.
**Locations**
Zurich, Switzerland
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
Leider ist dieser Job in Ihrer Region nicht verfügbar
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Market Development Representative (m/w/d)
Mellingen, Aargau
Veralto
Vor 4 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
Imagine yourself.
+ Doing meaningful work that makes an everyday impact on the world around you.
+ Thriving in a supportive team environment that inspires you to strive for excellence.
+ Joining a company with a proven track record of success and an exciting future.
It's all possible with a role at TraceGains. Headquartered in Broomfield, Colorado, TraceGains is a global technology company on a mission to revolutionize the agility of the consumer packaged goods (CPG) supply chain. We provide networked innovation, quality, and compliance solutions to consumer brands that want to reduce supply chain risk, accelerate business processes, and take control of data. We are in the game to change the industry, and with the help of our ever-growing TraceGains Network have created the CPG industry's first networked ingredients marketplace.
Reporting to the Director of Market Development, the Marketing Development Representative (MDR) will drive new business opportunities by developing relationships with inbound leads created by our marketing initiatives and warm/cold calls with contacts to create connections with potential clients.
In addition to converting leads generated from marketing campaigns, the MDR conducts research to identify new contacts, helps drive registration for events and webinars, sets appointments for Account Executives traveling out in the field, and drives meetings with target accounts during sponsored events.
Due to growth and expansion, this brand-new position will require a crucial understanding of the EU region and will be responsible for breaking into this new market.
This role will also collaborate and report to the EU Manager of Market Development to discuss messaging and prospecting initiatives.
**In this role, a typical day will be:**
+ Consistently achieve personal targeted monthly pipeline quotas and outbound generation goals.
+ Working closely with Marketing, Sales and Product departments to penetrate market segments, targeted accounts, and optimise event marketing.
+ Executing ABM marketing motions to generate leads from new clients and existing customers.
+ Developing strong knowledge of our product offerings and industry
+ Representing TraceGains at key field marketing events, acting as a brand ambassador
+ Proactively seek new business opportunities and contacts in the market by leveraging available tools (Zoominfo, Demandbase, LinkedIn, etc.).
+ Building rapport with prospective clients while working to qualify them. Act as liaison for the Account Executive, helping to book meetings and calls until hand-off is complete.
+ Gaining a deep understanding of inbound and outbound marketing programs, how leads are sourced and move through the funnel, along with knowledge of tactics that help re-engage stale leads.
+ Gaining a deep understanding of inbound and outbound marketing programs, how leads are sourced, and move through system, along with knowledge of tactics that help re-engage stale leads.
+ Contributing customer and sales insight to help with the creation of campaigns and initiatives that increase lead volume and revenue conversion for the business.
**You will ideally have:**
+ Proven success with prospecting and selling skills to land new accounts.
+ Minimum of 2 years of MDR/SDR, Sales, or Marketing related experience.
+ Proficiency in German (preferred) and English is essential (written and spoken).
+ Strong communicator and public speaker with excellent phone communication and presentation skills.
+ Experience in the food and beverage manufacturing industry would be a nice to have but not essential
+ Experience using Martech tools such as Salesforce, Outreach, SalesLoft, Sales Navigator, Demandbase, ZoomInfo, Enable or similar would be highly desirable but not essential
+ Willingness to learn and adapt as necessary to accommodate changes in industry and company directions.
+ Strong interpersonal skills and desire to work in a dynamic and fast-paced environment.
+ Ability to be a positive team player
+ Occasional domestic and international travel required for department meetings, all company events, in-person seminars/networking events, etc.
**Our Offer:**
You will join a growing, supportive and dynamic team focused on delivering results within an environment of continuous improvement and with an appreciation of diverse and creative strategies. Teamwork and enjoyment of your job is paramount. Personal and career growth at the core, and with an extremely competitive Base Salary and Generous uncapped Sales Incentive Plan.
The annual gross salary for this position starts at 45,000. Willingness to pay more is naturally present given appropriate experience and qualifications.
_Das Jahresbruttogehalt liegt für diese Position ab 45.000. Die Bereitschaft zur Überzahlung ist bei entsprechender Erfahrung und Qualifikation selbstverständlich vorhanden_
We know that innovation and ingenuity start with prioritizing a diverse workforce and a deeply inclusive workplace, and we encourage people from all backgrounds to apply for our positions.
TraceGains is proud to be part of the Product Quality & Innovation segment of Veralto (NYSE: VLTO), a $5B global leader dedicated to ensuring access to clean water, safe food and medicine, and trusted essential goods. When you join Veralto's vibrant global network of 16,000 associates, you join a unique culture and work environment where purpose meets possibility: where the work you do has an everyday impact on the resources and essentials, we all rely on, and where you'll have valuable opportunities to deepen your skillset, pursue your ambitions, and grow your career. Together, we're Safeguarding the World's Most Vital Resources-and building rewarding careers along the way.
At Veralto, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
**Unsolicited Assistance**
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at any of the Veralto companies ( , in any form without a valid, signed search agreement in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Veralto and its companies. No fee will be paid in the event the candidate is hired by Veralto and its companies because of the unsolicited referral.
Veralto and all Veralto Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
+ Doing meaningful work that makes an everyday impact on the world around you.
+ Thriving in a supportive team environment that inspires you to strive for excellence.
+ Joining a company with a proven track record of success and an exciting future.
It's all possible with a role at TraceGains. Headquartered in Broomfield, Colorado, TraceGains is a global technology company on a mission to revolutionize the agility of the consumer packaged goods (CPG) supply chain. We provide networked innovation, quality, and compliance solutions to consumer brands that want to reduce supply chain risk, accelerate business processes, and take control of data. We are in the game to change the industry, and with the help of our ever-growing TraceGains Network have created the CPG industry's first networked ingredients marketplace.
Reporting to the Director of Market Development, the Marketing Development Representative (MDR) will drive new business opportunities by developing relationships with inbound leads created by our marketing initiatives and warm/cold calls with contacts to create connections with potential clients.
In addition to converting leads generated from marketing campaigns, the MDR conducts research to identify new contacts, helps drive registration for events and webinars, sets appointments for Account Executives traveling out in the field, and drives meetings with target accounts during sponsored events.
Due to growth and expansion, this brand-new position will require a crucial understanding of the EU region and will be responsible for breaking into this new market.
This role will also collaborate and report to the EU Manager of Market Development to discuss messaging and prospecting initiatives.
**In this role, a typical day will be:**
+ Consistently achieve personal targeted monthly pipeline quotas and outbound generation goals.
+ Working closely with Marketing, Sales and Product departments to penetrate market segments, targeted accounts, and optimise event marketing.
+ Executing ABM marketing motions to generate leads from new clients and existing customers.
+ Developing strong knowledge of our product offerings and industry
+ Representing TraceGains at key field marketing events, acting as a brand ambassador
+ Proactively seek new business opportunities and contacts in the market by leveraging available tools (Zoominfo, Demandbase, LinkedIn, etc.).
+ Building rapport with prospective clients while working to qualify them. Act as liaison for the Account Executive, helping to book meetings and calls until hand-off is complete.
+ Gaining a deep understanding of inbound and outbound marketing programs, how leads are sourced and move through the funnel, along with knowledge of tactics that help re-engage stale leads.
+ Gaining a deep understanding of inbound and outbound marketing programs, how leads are sourced, and move through system, along with knowledge of tactics that help re-engage stale leads.
+ Contributing customer and sales insight to help with the creation of campaigns and initiatives that increase lead volume and revenue conversion for the business.
**You will ideally have:**
+ Proven success with prospecting and selling skills to land new accounts.
+ Minimum of 2 years of MDR/SDR, Sales, or Marketing related experience.
+ Proficiency in German (preferred) and English is essential (written and spoken).
+ Strong communicator and public speaker with excellent phone communication and presentation skills.
+ Experience in the food and beverage manufacturing industry would be a nice to have but not essential
+ Experience using Martech tools such as Salesforce, Outreach, SalesLoft, Sales Navigator, Demandbase, ZoomInfo, Enable or similar would be highly desirable but not essential
+ Willingness to learn and adapt as necessary to accommodate changes in industry and company directions.
+ Strong interpersonal skills and desire to work in a dynamic and fast-paced environment.
+ Ability to be a positive team player
+ Occasional domestic and international travel required for department meetings, all company events, in-person seminars/networking events, etc.
**Our Offer:**
You will join a growing, supportive and dynamic team focused on delivering results within an environment of continuous improvement and with an appreciation of diverse and creative strategies. Teamwork and enjoyment of your job is paramount. Personal and career growth at the core, and with an extremely competitive Base Salary and Generous uncapped Sales Incentive Plan.
The annual gross salary for this position starts at 45,000. Willingness to pay more is naturally present given appropriate experience and qualifications.
_Das Jahresbruttogehalt liegt für diese Position ab 45.000. Die Bereitschaft zur Überzahlung ist bei entsprechender Erfahrung und Qualifikation selbstverständlich vorhanden_
We know that innovation and ingenuity start with prioritizing a diverse workforce and a deeply inclusive workplace, and we encourage people from all backgrounds to apply for our positions.
TraceGains is proud to be part of the Product Quality & Innovation segment of Veralto (NYSE: VLTO), a $5B global leader dedicated to ensuring access to clean water, safe food and medicine, and trusted essential goods. When you join Veralto's vibrant global network of 16,000 associates, you join a unique culture and work environment where purpose meets possibility: where the work you do has an everyday impact on the resources and essentials, we all rely on, and where you'll have valuable opportunities to deepen your skillset, pursue your ambitions, and grow your career. Together, we're Safeguarding the World's Most Vital Resources-and building rewarding careers along the way.
At Veralto, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
**Unsolicited Assistance**
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at any of the Veralto companies ( , in any form without a valid, signed search agreement in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Veralto and its companies. No fee will be paid in the event the candidate is hired by Veralto and its companies because of the unsolicited referral.
Veralto and all Veralto Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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