A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
In this role you will be reporting into the Regulatory Global Therapeutic Area Head responsible for Neurology and Immunology products located in the Boston area (Billerica) development hub of EMD Serono and be aligned to exciting research and development projects for EMD Serono. You will be responsible for developing and leading Global regulatory strategies and leading submissions and approvals for clinical trials, and original marketing applications. In addition, you will serve as decision maker on submission readiness and represent the company at Health Authority meetings and other external forums.
Additional Responsibilities Include:
- Serving as the Global Regulatory Lead (GRL) representative on the Global Program/project team.
- Leading development of regulatory strategy, ensure global consistency, implementation and communication of strategy for the assigned product(s)
- Being accountable for regulatory strategic and operations matters within the Program / Project team for assigned projects
- Managing/leading strategic interactions with Health Authorities
- Leading the preparation, submission and approval of regulatory documents (e.g., clinical trial applications, orphan drug designation, Pediatric plans, and authority meeting packages) and marketing authorization applications globally or regionally
- Ensuring top regulatory quality across all Health Authority regulatory submissions and planning for production of dossier(s)
- Managing a global Regulatory Sub-team towards successful submission and approval of clinical trials, marketing authorizations as well as other strategic regulatory submissions (e.g. scientific advice, orphan designation applications, PIP, advisory committees, oral explanations, etc.)
- Providing global regulatory strategy input to meet target product profile and Health Authority expectations in key regions. Writing and keeping up to date the Regulatory Strategy Document (RSD)
- Communicating and defending global or regional regulatory strategies to the Global Project Team (or to the Regulatory Sub-team)
- Ensuring Health Authority as well as Health Technology Assessment input is incorporated into development decision making at GPT (Global Project Team) levels
- Working closely with the regional regulatory affairs to ensure regional RA input is considered in the global regulatory strategy
- Ensuring the understanding of the external regulatory competitive environment globally in order to adapt product regulatory strategy accordingly
- Planning for production of regulatory submission(s). Reviewing protocols, studying reports and all type of regulatory documentation (quality, safety, efficacy, PIP, ODD, labeling, IMPD, briefing documentation MAA/NDA…) before submission and decide on submission readiness
Who You Are:
- Bachelors degree in the Life Sciences or related discipline; advanced degree preferable
- Minimum of 10 years industry experience, with 8 years global regulatory experience
- Experience in preparation and management of comprehensive drug development programs (IND/CTA submissions for FIM to phase 3 and registration phase)
- Prior experience with Health Agency Interactions
- Experience with development and preparation of successful regulatory strategies and ability to write and defend such strategies
- Experience with regulatory project development activities and MAA/NDA management
- Experience as leading teams within a matrixed organization as well as direct report responsibilities
- Experience with both small molecules and biologics is an advantage
- Ability to lead GRA sub-teams and work collaboratively
- Prior experience with the development of neurology and /or immunology products is desired
- Excellent written and spoken communication skills along with strategic thinking and interpersonal skills
- Awareness of current trends in Regulatory Affairs
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.