Director of Regulatory Affairs

1 week ago

Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

Get AI-powered advice on this job and more exclusive features.

Senior Business Development Consultant at Black Swans Exist

Director 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

  1. Develop and execute global regulatory strategies for clinical development, Phase 2, and beyond.
  2. Oversee the preparation, review, and submission of INDs, CTAs, and other regulatory filings.
  3. Lead interactions with EMA and FDA, including scientific advice meetings, Type A/B/C meetings, and more.
  4. Craft and refine regulatory plans for biologics and combination products, considering EU and US requirements.
  5. Provide strategic and tactical guidance on regulatory submissions, study designs, and compliance.
  6. Build and enhance organizational capabilities in Regulatory Affairs, fostering a culture of operational and strategic excellence.

What We're Looking For

  1. Advanced degree in life sciences, pharmacy, or related fields.
  2. 10+ years of global Regulatory Affairs experience, particularly in biologics and combination products.
  3. Proven success with EMA and FDA submissions, and regulatory strategy development.
  4. Experience navigating complex regulatory landscapes, including CTA or IND approvals.
  5. A strategic mindset with operational agility, especially in biotech or small pharma environments.
  6. 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:

  1. Shape regulatory pathways for cutting-edge treatments.
  2. Engage directly with regulatory agencies to drive impactful decisions.
  3. 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 level

Director

Employment type

Full-time

Job function

Research and Science

Industries

Biotechnology Research and Pharmaceutical Manufacturing

#J-18808-Ljbffr

  • Director/Associate Director, Global Regulatory Affairs

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab AS Full time

    The 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 Specialist

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Jobindex AS Full time

    Join to apply for the Regulatory Affairs Specialist role at Jobindex A/SJoin to apply for the Regulatory Affairs Specialist role at Jobindex A/SDirect message the job poster from Jobindex A/SJobindex recruiting on behalf of clientWant to drive compliance across global markets and contribute to a mission of improving healthcare access worldwide?Join us as a...

  • Regulatory Affairs Specialist

    1 week ago

    Copenhagen, Copenhagen, Denmark Jobindex AS Full time

    Join to apply for the Regulatory Affairs Specialist role at Jobindex A/S Join to apply for the Regulatory Affairs Specialist role at Jobindex A/S Direct message the job poster from Jobindex A/S Jobindex recruiting on behalf of client Want to drive compliance across global markets and contribute to a mission of improving healthcare access worldwide? ...

  • Global Regulatory Affairs Leader

    2 weeks ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Seeking a Director/Associate Director to lead global regulatory affairs for CMC. This role will oversee the development and execution of sound and robust global regulatory strategies for biological products.

  • Senior Regulatory Affairs Process Manager

    5 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Job Overview:The role of Senior Manager, Regulatory Affairs Processes and Tools is a strategic position that oversees process improvements and the implementation of systems within Regulatory Affairs to ensure efficient regulatory support for the organization.This position is part of the Global Regulatory Affairs team and reports to the Sr Director Regulatory...

  • Director/Associate Director, Global Regulatory Affairs

    1 week ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    At 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.The RoleThe project portfolio at Genmab...

  • Regulatory Affairs Expert

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Blackswansexist Full time

    Job Description:Clinical-stage biotech company Blackswansexist is revolutionizing microbiome-based therapies for women's reproductive health. We are seeking a visionary Director of Regulatory Affairs to lead our global regulatory strategies.About the Role:Drive the regulatory framework for developing and approving innovative biologics, combination...

  • Regulatory Affairs Expert

    2 weeks ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Global Regulatory Affairs ProfessionalThis exciting opportunity is for a highly skilled and experienced Director/Associate Director to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible for operational and strategic regulatory CMC input to support worldwide development and commercialization.We are looking for a...

  • Associate Director, Global Regulatory Affairs, Strategy

    1 week ago

    Copenhagen, Copenhagen, Denmark Genmab AS Full time

    We are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science.The RoleGenmab is looking for an...

  • Regulatory Affairs Expert

    2 weeks ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Transforming Lives through Innovative Cancer TreatmentThe Role & ResponsibilitiesWe're seeking a seasoned regulatory expert to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this capacity, you will assume responsibility for the EU/ROW regulatory strategy, collaborating with the Global Regulatory Team on one or multiple...