A career with EMD Serono is an ongoing journey of discovery: our 50,000 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.
Global Regulatory Affairs (Development) is actively involved actively involved in the development of therapeutic medicines from POC through approval thereby contributing to strategy of the drug development path as well as to compliance with applicable pharmaceutical legislation / regulation.
The regulatory affairs Associate Director is to assume the role (or grow into the role, depending upon experience) of Global Regulatory Lead and/or 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 and annual report, pediatric plans, DSUR, PBRER). This role is specific to oncology or immune-oncology development projects for EMD Serono up to registration and in the early post-authorization phase. The successful candidate will:
- Ensure GRA-aligned regulatory input is incorporated into development decision making at the Global Project Team level. He/she is responsible for communicating global regulatory strategy and defending GRA positions to internal teams.
- Develop and implement global regulatory strategies to meet Health Authority expectations in target regions according to the RSD for the product concerned.
- Ensure an understanding of the external regulatory competitive environment globally in order to adapt product regulatory strategy accordingly.
- Ensure top quality across all regulatory submissions.
- Lead the benefit/ risk assessment of the product concerned, as called for in the iDP.
- Involve R&D QA in the development of project operational plans.
- Review and coordinate/contribute to responses to global Health Authority queries and to review and contribute to documents (e.g. protocols, reports) to be included in regulatory submissions (e.g. Clinical Trial Applications, IND, Scientific Advice, HA interactions, Answers to Authorities, PIP/PSP, ODD, DSUR).
Who you are:
- BS degree with 8+ yrs exp, MS degree with 3+ yrs exp, or PHD
- Fluent written and spoken English
- Ability to manage and/or lead regulatory submission process within the avelumab program
- Experience preparing and coordinating the production of all regulatory documentations
- Ability to contribute to development and evaluation of regulatory strategies for projects Excellent written and spoken communication skills in English
- Solid knowledge of regulations/development pathways in a minimum of one Region; growing understanding of additional major Regions
- Ability to think strategically
- Good interpersonal skills
- Attention to details
- Ability to lead and work in teams
- Awareness of current trends in regulatory affairs
- Business orientation
- Good 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 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.