Director of Regulatory Affairs
1 week ago
Get AI-powered advice on this job and more exclusive features.
Senior Business Development Consultant at Black Swans ExistDirector of Regulatory Affairs
Are you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a visionary Director of Regulatory Affairs to lead their global regulatory strategies.
About the Role
In this high-impact position, you will drive the regulatory framework for developing and approving innovative biologics, combination drug-device products, and companion diagnostics. You'll collaborate closely with cross-functional teams and regulatory authorities, ensuring strategies align with global standards and pave the way for clinical success.
Key Responsibilities
- Develop and execute global regulatory strategies for clinical development, Phase 2, and beyond.
- Oversee the preparation, review, and submission of INDs, CTAs, and other regulatory filings.
- Lead interactions with EMA and FDA, including scientific advice meetings, Type A/B/C meetings, and more.
- Craft and refine regulatory plans for biologics and combination products, considering EU and US requirements.
- Provide strategic and tactical guidance on regulatory submissions, study designs, and compliance.
- Build and enhance organizational capabilities in Regulatory Affairs, fostering a culture of operational and strategic excellence.
What We're Looking For
- Advanced degree in life sciences, pharmacy, or related fields.
- 10+ years of global Regulatory Affairs experience, particularly in biologics and combination products.
- Proven success with EMA and FDA submissions, and regulatory strategy development.
- Experience navigating complex regulatory landscapes, including CTA or IND approvals.
- A strategic mindset with operational agility, especially in biotech or small pharma environments.
- Strong leadership, interpersonal, and communication skills, adept at matrix management.
Moreover, you'll lead the charge in developing innovative therapies that transform the lives of millions. This role offers a unique opportunity to:
- Shape regulatory pathways for cutting-edge treatments.
- Engage directly with regulatory agencies to drive impactful decisions.
- Expand your career as the organization grows, taking on more projects and leadership opportunities.
Be part of the journey to redefine women's health.
If you're dynamic, flexible, and results-oriented with a passion for innovation, we'd love to hear from you.
Seniority levelDirector
Employment typeFull-time
Job functionResearch and Science
IndustriesBiotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr-
Regulatory Affairs Director
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the PositionWe are seeking a highly skilled Regulatory Affairs professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will have the opportunity to utilize your expertise to drive regulatory compliance and quality in clinical trials.ResponsibilitiesDrive regulatory compliance and quality in...
-
Regulatory Affairs Director Lead
4 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we're driven to push the boundaries of innovation in developing groundbreaking cancer treatments and therapies.Director/Associate Director, Global Regulatory Affairs - CMCWe're seeking a seasoned Regulatory Affairs Director Lead to join our team and play a pivotal role in shaping the future of biologics development. As a key member of our CMC...
-
Regulatory Affairs Director
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeOur CultureGenmab fosters a culture of collaboration, mutual respect, and open communication. Our team is composed of talented individuals who share a passion for innovation and excellence. We strive to create an environment where every employee feels valued, supported, and empowered to contribute to our shared success.About the PositionWe're seeking a...
-
Regulatory Affairs Director
11 hours ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeThe Director of Regulatory Affairs at Black Swans Exist plays a pivotal role in ensuring the company's products meet global regulatory requirements. This position focuses on compliance with regulations set by authorities such as the FDA and EMA, ensuring timely updates for existing products. The ideal candidate will have deep expertise in drug regulations...
-
Regulatory Affairs Director
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products that change the lives of patients and the future of cancer treatment.The Regulatory Affairs CMC team is evolving and we are therefore looking for a Director/Associate Director to join our dynamic team. The successful candidate will be responsible...
-
Regulatory Affairs CMC Director
1 day ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the RoleThe Regulatory Affairs CMC team at Genmab is seeking a highly experienced Director/Associate Director to support worldwide development and commercialization of biological products.As a key member of the team, you will be responsible for developing and executing sound global regulatory CMC strategies for early and late-stage development, as well...
-
Director of Regulatory Affairs
2 weeks ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeThe Director of Regulatory Affairs ensures that the company's products meet global regulatory requirements, focusing on the USA and Europe, including those set by the FDA, EMA, and other relevant authorities. This role is responsible for developing and executing regulatory compliance strategies, navigating approval processes for pharmaceuticals and medical...
-
Regulatory Affairs Director for Biologics
1 week ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeCompany OverviewBlack Swans Exist is a pioneering biotech company dedicated to revolutionizing microbiome-based therapies for women's reproductive health. Our vision is to develop innovative biologics and combination drug-device products that improve women's lives.The PositionWe're seeking an experienced Director of Regulatory Affairs to lead our global...
-
EU/ROW Regulatory Affairs Director
7 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout YouWe are looking for a highly experienced Senior Director to join our Global Regulatory Affairs organization in the EU/ROW region. As a key member of our team, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.The successful...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe're dedicated to creating life-changing treatments at Genmab, and we're seeking a highly skilled Biopharmaceuticals Regulatory Affairs Specialist to join our Regulatory Affairs CMC team.Director/Associate Director, Global Regulatory Affairs - CMCIn this critical role, you will be responsible for providing regulatory CMC input to support worldwide...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Workday@Genmab.com.Director/Associate Director, Global Regulatory Affairs - CMCAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering...
-
Regulatory Affairs Leader
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking an experienced leader to join our Global Regulatory Affairs organization as a Senior Director, Regulatory Affairs Strategy-EU/RoW. This role will be responsible for developing global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products.The ideal candidate will have a strong...
-
Senior Director, Global Regulatory Affairs
7 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are looking for a Senior Director to join our Global Regulatory Affairs organization in the EU/ROW region. As a key member of our team, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.The successful candidate will have...
-
Regulatory Affairs Manager
1 week ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeInnovative solutions for a better tomorrowRadiometer Danmark / Danaher is committed to improving global healthcare with reliable, fast, and easy patient diagnoses. We strive to make a difference in people's lives by providing cutting-edge technology and solutions.The Senior Manager, RA Processes, Systems and Tools plays a crucial role in driving process...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We believe that being proudly unique,...
-
Director of Regulatory Affairs EU/ROW Lead
4 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the RoleGenmab is seeking an experienced Senior Manager/Associate Director to lead our Global Regulatory Affairs organization as EU/ROW Regulatory Lead. In this role, you will represent RA in Clinical Trial Teams and work closely with CROs and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions in EU/ROW.Key...
-
Global Regulatory Affairs Leader
24 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob DescriptionWe are looking for a skilled Director/Associate Director to join our Regulatory Affairs CMC team in Copenhagen, Denmark.You will be responsible for operational and strategic regulatory CMC input to support worldwide development and commercialization of biological products. Your main duties will include developing and executing sound global...
-
Biotech Regulatory Affairs Lead
1 week ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeAbout Black Swans ExistBlack Swans Exist is a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health. We are shaping the future of women's health by developing innovative biologics and combination drug-device products.The RoleWe seek a visionary Director of Regulatory Affairs to lead our global regulatory...
-
Regulatory Affairs Strategist
7 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeGenmab A/S is dedicated to creating life-changing antibody therapeutics for patients with cancer and other serious diseases. As a Regulatora Affairs Strategist in our Global Regulatory Affairs organization, you will play a key role in shaping the regulatory strategy for our products.Your primary responsibility will be to support the Global Regulatory Lead...
-
Biotechnology Regulatory Affairs Expert
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeCompany OverviewGenmab is a leading biotechnology company with a strong commitment to improving the lives of patients through innovative and differentiated antibody therapeutics. With a core purpose guiding its unstoppable team, Genmab strives towards transforming the lives of people with cancer and other serious diseases.About the RoleThe Regulatory Affairs...