Global Regulatory Lead
4 months ago
Are you an experienced Regulatory Affairs Professional, and do you want to help drive the development of the current and next generations of Ferring’s health care solutions that help people live better lives?
Then come join us in a challenging position in one of our Global Regulatory Affairs Therapeutic Area teams.
Ferring is dedicated to advancing innovative therapies for the treatment of diseases within the Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas.
Our comprehensive approach encompasses a diverse range of treatment solutions. We strive to lead in innovation and adopt a global perspective, starting from the early stages of development.
We invite you to leverage your extensive regulatory expertise to drive the progression of our development projects and/or key marketed products within these fields. In return, we offer you the freedom to impact our ways of working and expand your personal toolkit along the way. We offer an exciting job in a company with an entrepreneurial and inclusive work environment and great opportunities to develop. At Ferring, People come first. Your contributions will be valued, and your efforts will make a true impact on the business and for the many people in need of health care solutions within our therapeutic areas. You will work in an international environment in a global HQ capacity and enjoy close collaboration with colleagues across the global functions and in our regional and affiliate offices.
Ferring+You
In your role you will work in a team of highly skilled regulatory professionals responsible for the global regulatory activities for our development projects and marketed products. In the Therapeutic Area Teams, we have the overall responsibility for developing and executing the global regulatory strategies, including worldwide submission planning, market expansions and label expansions.
Your day at Ferring
Reporting to the Senior Director in the Therapeutic Area team, you will be assigned to one or more projects or marketed products, and your responsibilities may encompass the following:
- Represent GRA in the Global Project Team and chair the Global Regulatory Teams providing regulatory strategic expert input to drive project/product progression.
- Drive the development of high-quality global regulatory strategies, including identifying regulatory opportunities and mitigation of risks, strategic submission and regulatory activity planning, and development of competitive labels in collaboration with relevant team members and stakeholders.
- Plan and manage meetings with health authorities worldwide for the projects/products assigned. Drive and lead the preparation of high-quality briefing packages, liaising with health authorities and experts to obtain scientific advice to mitigate regulatory risks and enable project progression.
- For late-stage projects, ensure submission and approvals of BLAs/MAAs in US, EU, Japan, China and other countries worldwide in collaboration with local regulatory colleagues, and drive the strategic planning of market expansions, including responses to authority inquiries.
- For marketed products, prepare the regulatory LCM strategy and manage the strategic planning and execution of regulatory submissions and approvals for worldwide market expansions, renewals, and variations for the products assigned, leading the submission team and chairing the Labelling Management Team.
- Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide input to clinical and nonclinical documentation and represent GRA in our Clinical Development, Safety Management teams, and/or Clinical Trial Team.
- Represent GRA in project presentations and discussions with upper management and governance bodies at project milestones.
- Provide regulatory input to evaluation of external business opportunities (due diligence).
- Contribute to the continuous improvement of the department and GRA working processes.
Your new workplace will be our spectacular, state-of-the-art new domicile Soundport in Copenhagen, overlooking the ocean and close to the Airport and the Oresund bridge, with the option of working from home 2 days a week.
Candidates must be located in the Copenhagen region or willing to relocate at their own expense.
Behind our innovation…There’s you
- University degree in science (life science, 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.
- Experience managing global regulatory activities and driving regulatory strategic project discussions, including preparing regulatory strategies and submissions.
- Strong negotiation skills, solid judgement, and effective decision-making abilities.
- Proactive, strategic and team player with a positive mindset and a 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.
People come first at Ferring
Get inspired from our commitment to advocate for everyone’s right to build a family, no matter who you are, where you live or who you love.
Our inclusive support package – “Building Families at Ferring” provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role:
- Parental leave for both birthing and non-birthing parents.
- Extended support on family building journey.
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions. Imagine the power of your career when it’s Ferring + You.
Behind our purpose… There’s you
If our mission and your vision are aligned, please apply.
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.
If you have any questions, you are welcome to contact the Talent Acquisition Sourcer, Patricia Martins ( ).
Note to agencies: this search is being managed by Ferring’s Talent Acquisition team. Kindly do not send us spontaneous profiles.
Ferring Pharmaceuticals is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. At Ferring International PharmaScience Center (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists working to break new land to help people live better lives. We focus our R&D efforts on peptide-based drugs and biotechnology derived medicines.
Location:
Ferring Denmark
-
København, 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. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...
-
København, 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. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...
-
Global Regulatory Affairs Manager – CMC
4 months ago
København, Denmark Ferring Pharmaceuticals AS Full timeWould you like to join an international company with excellent development opportunities and an open work environment where your contributions will make a difference, as you take on CMC responsibility for one of our products and a development project? You will be part of our Small Molecule team, which is responsible for all global regulatory CMC activities...
-
Associate Director, EU/ROW Regulatory Lead
4 months ago
København, 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 . Associate Director, EU/ROW Regulatory Lead page is loaded Associate Director, EU/ROW Regulatory Lead Apply locations Copenhagen time type Full time posted on ...
-
Regulatory Director
3 weeks ago
København, Denmark AstroPay Corporation LLP Full timeThe Regulatory Director will serve as a key regional leader for the company’s regulatory strategy and compliance framework, ensuring alignment with global objectives while addressing the unique requirements of local markets. Acting as a bridge between the VP of Public Policy & Regulatory Affairs, other Regional Regulatory Directors, and local teams, this...
-
København, 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 Director/Associate Director, Global Regulatory Affairs - CMC At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that...
-
København, 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...
-
Senior Director, Regulatory Affairs Strategy-EU/RoW
4 months ago
København, Denmark Genmab AS Full timeSenior Director, Regulatory Affairs Strategy-EU/RoW 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...
-
Senior Director, Regulatory Affairs Strategy-EU/RoW
4 months ago
København, Denmark Genmab Full timeAt Genmab, we’re committed to building extra(not)ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off 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...
-
Regulatory Manager
4 months ago
København, Denmark Nordea Full timeKøbenhavn S, DK, 2300 Job ID: 23315 Are you passionate about navigating regulatory changes and staying ahead of the regulatory trends? We are seeking a dynamic Regulatory Manager to join our team and support our organization in analyzing the impact of upcoming EU and local Nordic regulatory changes. At Nordea, we’re committed to being a partner our...
-
Senior Regulatory Scientist
4 months ago
København, Denmark Voisin Consulting SARL Full timeSenior Regulatory Scientist We are continuing to invest in growing our Nordic business and are now seeking to hire Senior Regulatory Scientists. This role will speak to those who are excited at the pace of change and innovation in Life Science, who want have an appetite to partner the most cutting edge clients and those who want to continuously learn,...
-
Regulatory MA Deputy Manager
4 months ago
København, Denmark ABACUS MEDICINE AS Full timeDrive meaningful change in Regulatory Marketing Authorization In Regulatory, we obtain licenses for parallel trading of medicine. We do this by submitting applications to the European Medicines Agency and national medicine agencies of our sales countries. Our department is responsible for making sure that Abacus Medicine can parallel trade medicines as...
-
Global Head of Websites and Leads
5 days ago
København, Denmark Saxo Bank Full timeGlobal Head of Websites and Leads Apply locations Headquarters time type Full time posted on Posted 5 Days Ago job requisition id R-16839 Copenhagen, Denmark As our new “Global Journey Owner - Websites and Leads” you will take full ownership of Saxo Bank’s commercial website home.saxo. You will be driving significant business impact through aligning...
-
Regulatory Data Analyst Finance
4 weeks ago
København, Denmark Lunar Denmark Full timeAre you ready to redefine regulatory reporting? At Lunar , we are democratizing the power of money and changing the way we all bank, pay, and invest. Since starting in Aarhus in 2015, we've grown rapidly and are now a major player in the Nordics, with offices in Copenhagen, Aarhus, and Stockholm. So who are we? Are we a tech company or a bank? Well, we're...
-
København, Denmark Ascendis Pharma AS Full timeAre you passionate about changing the lives of people living with rare diseases? Do you have experience with planning and executing Global Medical Affairs external programs? If so, now is your chance to join Ascendis Pharma as our new Associate Director, External Programs in Global Medical Affairs. Ascendis Pharma is a fast-growing biopharmaceutical company...
-
Financial Crime
3 months ago
København, Denmark Saxo Group Full timeFinancial Crime & Regulatory Specialist Copenhagen, Denmark Do you want to work with the AML advisory team on high-risk assessments globally? Are you interested in working in a highly important area within Financial Crime Prevention in a complex and exciting organization? Then we have the right opportunity for you! With an important focus on Financial Crime...
-
København, Denmark Saxo Group Full timeGlobal Head of Corporate Communications, PR, and Organic Social Media Copenhagen, Denmark About the job: Are you ready to elevate Saxo's PR and communications efforts to new heights? We are seeking a dynamic senior leader to join us as the Global Head of Corporate Communications, PR, and Organic Social Media. In this role, you will be at the forefront of...
-
Senior Director, Global Real World Evidence
4 months ago
København, Denmark Ferring Pharmaceuticals Full timeJob Description:As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people...
-
København, 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. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...
-
Global Head of Air Charter
4 months ago
København, Denmark Maersk Group - A.P. Møller Mærsk Full timeAre you a visionary leader with a passion for aviation and logistics? Do you thrive in dynamic, fast-paced environments and excel at creating innovative solutions? Maersk is looking for someone to spearhead our Air Charter business globally, ensuring efficiency, profitability, and a strong reputation for quality, reliability, and exceptional customer...
