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 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.
Global Regulatory Affairs 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.
In this role you will support the 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 (e.g. orphan designation, annual report, pediatric plans, DSUR).
- Manage the regulatory submission including management and coordination of the preparation of all regulatory documentations at different Regulatory milestones
- Manage the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (under supervision of a Therapeutic Area Head or Regulatory Strategist)
- Contribute to the development and evaluation of regulatory strategies for projects
- 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:
- Degree in Life Science or related discipline, higher degree preferable (Pharm.D., MSc, PhD, MBA)
- Minimum of 8 years’ regulatory experience
- Experience with preparation and writing regulatory documentation to support agency interactions
- Experience with the clinical trial phase of development, e.g. IND / CTA / eCTD requirements
- Experience with maintenance of regulatory authorizations in at least one region
- Experience with supporting a project with development activities in at least one region
- Experience in oncology preferred
- Excellent written and spoken communication skills
- Good interpersonal skills
- Attention to detail
- Ability to work in teams
- Strong organizational and planning skills
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.