CMC Regulatory Expert
4 weeks ago
Ferring Pharmaceuticals A/S is a global company that helps people build families and live better lives. We are committed to scientific advances in reproductive and women's health, gastroenterology, and urology.
Job Title: CMC Regulatory Expert - Product LifecycleWe are seeking an experienced Global Regulatory Affairs Manager to join our team as a CMC Regulatory Expert - Product Lifecycle. This role will be responsible for the lifecycle projects for one of our products.
About the RoleIn this challenging position, you will work closely with stakeholders, project teams, and colleagues within global regulatory affairs to ensure timely worldwide market expansions and approvals. Your main responsibilities will include:
- Regulatory CMC strategy and expertise to cross-functional teams.
- Performing regulatory impact assessments of CMC changes.
- Ensuring adequate documentation is generated, submitted, and approved timely worldwide.
To succeed in this role, we believe your CV should comprise:
- +5 years of experience in global regulatory affairs preferably within regulatory CMC activities.
- M.Sc. in a life science or pharmacy.
- Facilitation of risk management discussions is an asset.
You will be part of our Small Molecule team who are responsible for the small molecules and peptides products. The department has robust expertise with small molecules, peptides, biologics, recombinant products, and is expanding to also excel in other modalities including gene therapy.
BenefitsAs a Global Regulatory Affairs Manager at Ferring Pharmaceuticals A/S, you will enjoy:
- A competitive salary range of approximately 85000-115000 DKK per annum.
- A dynamic and entrepreneurial work environment.
- Ongoing career development opportunities.
-
Strategic Regulatory CMC Expert
2 months ago
Copenhagen, Copenhagen, Denmark Genmab Full timeRole OverviewThe Regulatory Affairs CMC team at Genmab is seeking a highly skilled Associate Director to provide strategic regulatory CMC input to support worldwide development and commercialization.ResponsibilitiesDevelop and Execute Global Regulatory CMC Strategies: Develop and execute sound and robust global regulatory CMC strategies for biological...
-
Global Regulatory Affairs Specialist
2 months ago
Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full timeAbout the RoleFerring Pharmaceuticals A/S is seeking an experienced Global Regulatory Affairs Manager - CMC to join our team. In this role, you will be responsible for the lifecycle projects for one of our products, collaborating with stakeholders, project teams, and colleagues within global regulatory affairs.Main ResponsibilitiesRegulatory Submissions and...
-
Expert CMC Technical Integration Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe are committed to building extraordinary futures together, by developing innovative products and pioneering therapies that change the lives of patients and the future of cancer treatment.Genmab is now searching for a (Senior) CMC Technical Integration Manager to join the CMC Integration Team in New Product Introduction (NPI) CMC. The NPI CMC Team is...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs CMC team. This is an exciting opportunity to work in a dynamic and innovative environment, collaborating with talented colleagues in Regulatory Affairs and within Genmab's CMC organization.Key...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timePharmaceutical Quality Expert OpportunityWe are seeking a highly skilled Lead Pharmaceutical Quality Expert to join our CMC Development team at Lundbeck. This exciting role offers the chance to make a significant impact on the development of innovative treatments for brain diseases.About the Role:The successful candidate will be responsible for ensuring GMP...
-
Global Regulatory Affairs CMC Strategist
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeOverviewGenmab, a dynamic and innovative biotechnology company, is seeking an experienced Associate Director to join its Global Regulatory Affairs CMC team. This role offers an exciting opportunity to contribute to the development and commercialization of biological products worldwide.
-
Regulatory Affairs Director
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout GenmabWe are a global biotechnology company dedicated to creating innovative antibody therapies that transform lives. Our passionate team of experts is driven by a shared purpose: to improve patient outcomes through cutting-edge science and collaboration.Job OverviewWe seek an experienced Director/Associate Director, Regulatory Affairs CMC to join our...
-
Transformational Biopharmaceutical Project Lead
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we are currently seeking a highly skilled Senior CMC Project Manager to join our Late-stage Manufacturing Development (LSMD) Team in Copenhagen.The LSMD CMC Team is an integral part of CMC Operations, which boasts a team of close to 30 employees. As a key member of this team, you will be responsible for coordinating and planning activities...
-
Regulatory Affairs Director
1 month ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeThe Regulatory Affairs CMC team at Genmab is seeking a Director/Associate Director to support worldwide development and commercialization of biological products. The ideal candidate will have a strong understanding of compliance and biologics, with a track record of moving therapeutic products through various stages of development.Key Responsibilities:...
-
CMC Technical Integration Specialist
1 month ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the RoleWe are seeking a highly skilled Senior CMC Technical Integration Manager to join our CMC Integration Team in New Product Introduction (NPI) CMC. As a key member of the team, you will be responsible for developing and supporting analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio.Key...
-
Quality Assurance Expert for CMC Development
3 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeLundbeck is a leading pharmaceutical company with a commitment to developing innovative treatments for brain diseases.We are currently seeking a Quality Assurance Expert for our CMC Development department in Copenhagen, Denmark. This exciting role offers the opportunity to work on a global scale and contribute to the development of new treatments for brain...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeLundbeck is a global leader in the development and manufacturing of innovative treatments for brain diseases.As Senior Vendor Expert, CMC Development Oversight Specialist, you will play a key role in our vendor management program, ensuring compliance and quality assurance for our clinical trials.The ideal candidate holds a master's degree in pharmacy,...
-
Global Regulatory Expert
1 month ago
Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full timeTransformative Regulatory Leadership OpportunityFerring Pharmaceuticals A/S is dedicated to advancing innovative therapies for the treatment of diseases within the Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas. We are seeking an exceptional Global Regulatory Lead to join our Global Regulatory Affairs team in Copenhagen.This is a...
-
Global Regulatory Affairs Expert
1 month ago
Copenhagen, Copenhagen, Denmark WSAudiology Full timeAt WSAudiology, we're navigating a rapidly evolving regulatory landscape and seeking a Global Senior Regulatory Affairs Specialist to join our team.This pivotal role will ensure that our products meet the highest standards of compliance. As a key member of our global Regulatory Affairs team, you'll be integral to day-to-day regulatory problem-solving and...
-
Regulatory Affairs Expert
2 months ago
Copenhagen, Copenhagen, Denmark Voisin Consulting SARL Full timeSenior Regulatory Scientist RoleWe are continuing to grow our Nordic business and are now seeking a Senior Regulatory Scientist. This role is suitable for those who are excited at the pace of change and innovation in Life Science, who want to partner with cutting-edge clients and continuously learn, develop, and progress personally and professionally.Key...
-
Strategic Director, Regulatory Affairs Expert
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we are dedicated to creating extraordinary futures by developing pioneering antibody products and therapies that transform the lives of patients with cancer and serious diseases. Our commitment to innovation and science is rooted in our people who are caring, candid, and impact-driven.The Role We are seeking an experienced leader to join our...
-
CMC Senior Project Manager
2 months ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled CMC Senior Project Manager to join the Late-Stage Manufacturing Development Team in Copenhagen.This is a key position responsible for coordinating and planning CMC activities at Contract Manufacturing Organizations (CMOs) in support of Genmab's late-stage development programs.Main ResponsibilitiesCMC project...
-
Senior Regulatory Affairs Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeTransform the lives of patients with innovative cancer treatment by joining our dynamic team at Genmab A/S as a Senior Regulatory Affairs Manager for Biological Products.About the RoleWe are seeking a seasoned professional to lead our regulatory affairs efforts in the CMC department. As a Senior Regulatory Affairs Manager, you will be responsible for...
-
Regulatory Systems Management Expert
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is a global biotechnology company that develops innovative antibody therapeutics. Our team of experts strives to transform the lives of patients with cancer and other serious diseases.We are currently seeking a skilled Regulatory Systems Management Expert to join our team. This is an exciting opportunity for a motivated professional to take on a key...
-
Regulatory Expert with Global Reach
2 weeks ago
Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full timeUnlock Your Potential as a Regulatory ExpertFerring Pharmaceuticals A/S is seeking an experienced Global Regulatory Lead to join our team in Copenhagen, Denmark. As a key member of our regulatory affairs department, you will play a critical role in driving the development and implementation of global regulatory strategies for our innovative healthcare...