Regulatory Expert with Global Reach

1 month ago

Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full time
Unlock Your Potential as a Regulatory Expert

Ferring 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 solutions.

About the Role

  • You will be responsible for representing GRA in global project teams, chairing regulatory teams, and providing strategic input to drive project progression.
  • Develop high-quality global regulatory strategies, including identifying opportunities and mitigating risks, submission planning, and competitive labeling.
  • Plan and manage meetings with health authorities worldwide, preparing briefing packages, and liaising with experts to obtain scientific advice.
  • Ensure submission and approval of BLAs/MAAs in major markets, drive market expansions, and respond to authority inquiries.
  • Manage LCM strategy, execute regulatory submissions, and approvals for worldwide market expansions, renewals, and variations.
  • Compile, submit, and maintain CTAs and INDs for clinical trial-related activities, providing input to clinical and non-clinical documentation.
  • Represent GRA in project presentations, discussions with upper management, and governance bodies at project milestones.
  • Provide regulatory input to evaluation of external business opportunities.
  • Contribute to the continuous improvement of GRA working processes.

Your Background

  • University degree in science (life sciences, health, or medical sciences).
  • +8 years of comprehensive experience with drug development from phase 1 to launch, including health authority interactions (FDA, EMA, Japan, and China).
  • Experience with labelling, clinical trials, and other clinical and non-clinical regulatory activities.
  • Strong negotiation skills, solid judgment, and effective decision-making abilities.
  • Proactive, strategic, and team player with a positive mindset and constructive attitude towards driving results.
  • Able to work in an international corporate environment with a diverse and fast-paced workday.
  • Fluency in English, excellent verbal and written communication skills.

We Offer

  • An estimated salary range of €90,000 - €120,000 per annum, commensurate with experience.
  • A dynamic and inclusive work environment with a focus on innovation and collaboration.
  • The opportunity to work on cutting-edge projects that make a meaningful impact on people's lives.
  • A comprehensive benefits package, including parental leave, extended support for family building, and a global standard for equal access to fertility treatments.
  • A chance to contribute to a company that prioritizes diversity, equity, and inclusion, and strives to create a workplace where everyone feels valued and respected.

About Ferring Pharmaceuticals A/S

Ferring Pharmaceuticals A/S is a leader in reproductive medicine and maternal health, with a strong presence in gastroenterology and urology. Our Copenhagen office is home to nearly 600 scientists and specialists who are passionate about breaking new ground to help people live better lives. We focus our R&D efforts on peptide-based drugs and biotechnology-derived medicines, and we are committed to advancing innovative therapies that address unmet medical needs.

  • Global Regulatory Lead

    2 months ago

    Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full time

    Unlock Your Potential as a Global Regulatory Affairs ProfessionalFerring 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 strive to lead in innovation and adopt a global perspective, starting from the early stages of...

  • Chemical Stewardship Expert with Global Regulatory Acumen

    2 months ago

    Copenhagen, Copenhagen, Denmark Brinch & Partners Full time

    About UsTopsoe is a leading global provider of technology and solutions for the energy transition.We combat climate change by helping our customers and partners achieve their decarbonization and emission reduction goals.Based on decades of scientific research and innovation, we offer world-leading solutions for transforming renewable resources into fuels and...

  • Senior Regulatory Affairs Expert

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Unlock your potential in a dynamic environment at Genmab, a pioneering biotechnology company dedicated to transforming the lives of patients through innovative cancer treatments and therapies. As a Senior Regulatory Affairs Expert, you will play a pivotal role in shaping our regulatory strategies and ensuring seamless clinical trial submissions.About the...

  • Regulatory Systems Management Expert

    2 months ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab 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 Affairs Specialist with Global Perspective

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full time

    Unlock Your Expertise as a Regulatory Affairs SpecialistFerring Pharmaceuticals A/S is dedicated to advancing innovative therapies for the treatment of diseases within Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas. As a Regulatory Affairs Specialist, you will play a crucial role in driving the development of our current and...

  • Global Regulatory Affairs Strategist

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab AS 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. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...

  • Trade Compliance Expert with Global Reach

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Grohe AG Full time

    Job DescriptionWe are seeking a highly skilled Trade Compliance Expert to join our team at GROHE AG. This role will be responsible for ensuring that all entities within the GROHE Holding Subgroup comply with national and international trade control, export control, and sanction regulations.Key ResponsibilitiesCoordinate and manage trade compliance activities...

  • Global Regulatory Risk Manager

    1 month ago

    Copenhagen, Copenhagen, Denmark Ramboll Group AS Full time

    Job DescriptionWe are seeking a highly skilled Global Regulatory Risk Manager to join our team as a Strategic Compliance Lead. As part of this role, you will be responsible for managing two subject matter experts in the Global Speak Up Team, investigating suspicious activities and handling concerns reported under our global Whistleblower programme.You will...

  • Global Regulatory Affairs Director

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full time

    About Ferring PharmaceuticalsFerring Pharmaceuticals A/S is an innovative company that empowers employees to achieve excellence together. Our mission is to help people around the world build families and live better lives.Job Description: Global Regulatory Affairs Director - Small MoleculesThe ideal candidate will be responsible for leading CMC regulatory...

  • Global Regulatory Affairs Expert Seeking Exciting Opportunity

    1 month ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking an experienced Associate Director, Global Regulatory Affairs Project Lead to join our team at Genmab.Job DescriptionIn this role, you will be responsible for representing RA in Clinical Trial Teams and ensuring regulatory oversight and progress of clinical trial submissions in EU/ROW. You will also work closely with CROs and...

  • Regulatory Affairs Expert

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Voisin Consulting SARL Full time

    We are seeking a talented Regulatory Affairs Expert to join our team at Voisin Consulting SARL. This role will be responsible for developing and executing regulatory strategies for assigned projects, including the preparation and submission of regulatory filings.Key Responsibilities:Develop Regulatory Strategies: Create and implement effective regulatory...

  • Senior Sales Professional with Global Reach

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Cision Denmark ApS Full time

    Cision Denmark ApS is a leading provider of social media monitoring and analytics solutions, operating in 17 offices across the globe. As an Account Executive with our company, you will play a key role in driving sales growth by identifying client needs and showcasing our platform's capabilities.The ideal candidate will have a proven track record in sales,...

  • Global Trade Compliance Expert

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Organon ApS Full time

    Job Overview:We are seeking a highly skilled Global Trade Compliance Expert to join our team at Organon ApS. As a key member of our Global Logistics Services team, you will be responsible for ensuring compliance with all applicable laws and regulations for import/export across different regions.About the Role:The successful candidate will orchestrate...

  • Regulatory Affairs Project Lead

    2 months ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    We are seeking a highly skilled and experienced Regulatory Affairs Project Lead to join our Global Regulatory Strategy team at Genmab. This role will be responsible for developing and executing EU/ROW regulatory strategies for assigned projects, ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Lead the development of...

  • Leadership Role in Global Regulatory Affairs

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the PositionGenmab is seeking an experienced Senior Director to lead our Global Regulatory Affairs organization. As a key member of our team, you will be responsible for developing and executing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.Key Responsibilities:Develop and implement...

  • Quality Assurance and Regulatory Expert for Medical Devices

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    Job OverviewWe are seeking a highly skilled Quality Assurance and Regulatory Expert to join our Clinical and Regulatory team at Radiobotics. As a QA/RA specialist, you will play a critical role in maintaining superior product quality and driving the placement of our products in new markets.

  • Strategic Director, Regulatory Affairs Expert

    1 month ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    At 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...

  • Global Development Professional

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Dalberg Global Development Advisors Full time

    About the RoleWe are seeking a highly skilled and innovative Global Development Professional to join our team as a Communications Expert. This is an exciting opportunity for a motivated individual to contribute to our mission-driven communications and experience consultancy, empowering people to solve global development challenges.Key ResponsibilitiesSupport...

  • Regulatory Affairs Process Manager, Global Innovations

    1 month ago

    Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    At Radiometer Danmark / Danaher, we're committed to improving global healthcare with reliable, fast, and easy patient diagnoses. We're seeking a highly skilled Senior Manager, RA Processes, Systems and Tools to join our team.The ideal candidate will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs...

  • Global Regulatory Affairs Project Lead

    2 months ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to developing innovative antibody therapies that change the lives of patients and the future of cancer treatment. As a Global Regulatory Affairs Project Lead, you will play a key role in shaping our regulatory strategy for EU/ROW.About the Role:You will represent RA in Clinical Trial Teams and ensure regulatory oversight and...