Global Regulatory Lead

3 months ago

Kastrup, Denmark Ferring Pharmaceuticals Full time

Job Description:

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)

+ 8years 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.

Location:

Ferring Denmark

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