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Senior Manager, Global Regulatory Affairs, Neurology & Immunology
A career with EMD Serono is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 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.
This role can be located in our Billerica, MA, Rockland, MA or remote work arrangement.
Global Regulatory Affairs is a dynamic team that is actively involved in the development and life-cycle management of medicinal products thereby contributing to appropriateness of the drug development path as well as to compliance with applicable pharmaceutical legislation / regulation. The purpose of the regulatory affairs support is to assist the global regulatory lead and/or the Regional lead in preparation and execution of global regulatory strategies and to manage the submission and approval of applications for clinical trials, marketing applications or other related regulatory submissions (orphan designation, annual report, pediatric plans and DSUR etc.)
- Manage the regulatory submission including management and coordination of the preparation of all regulatory documentations at different Regulatory milestones
- Manage of the regulatory agency interactions, document preparation, coordination rehearsals and minutes (under supervision of a Therapeutic Area Head or Regulatory Strategist)
- Contribute development and evaluation of regulatory strategies for projects (under supervision of the Regulatory Strategist)
- Review and provide regulatory comments to quality-, safety- and efficacy or labeling related documents (e.g. protocols, reports) to be included in a regulatory submission (e.g. Clinical Trial Applications, IND, Scientific Advice, HA interactions, Answers to Authorities, PIP/PSP, ODD, DSUR…)
- Contribute to the development of risk assessment pertaining to the quality-, safety- and efficacy documentation/data of investigational medicinal products related applications.
Who you are:
- Bachelor’s degree in Life Science or related discipline.
- Excellent spoken and written English
- Minimum of 5 years’ industry experience of which at least 3 years’ US regulatory experience
- Experience with preparation and writing regulatory documentation to support agency interactions
- Experience in IND / CTA / eCTD requirements
- Knowledge of international regulatory affairs
- Advanced Degree (Pharm.D., MSc, PhD, MBA)
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 https://jobs.vibrantm.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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.