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.
An exciting new opportunity has arisen to join EMD Serono as a Sr. Regulatory Project Manager. In close collaboration with the Global Regulatory Lead you are accountable for the operational aspects of regulatory deliverables within Development Projects. As a member of the regulatory sub team you plan, manage, track and ensure on-time production of regulatory deliverables for all submissions during development including initial MAA for US and EMA. As the leader of the Submission Taskforce you lead a cross functional team ensuring delivering of all dossier components, review and approval for submissions and coordinating the response to questions. As subject matter expert in the Global Project Team you provide timelines, direct cost demand and dashboards for Global Regulatory Affairs.You coach junior regulatory project managers and actively participate to the development of competences within the Regulatory Affairs project manager community.As a Sr. Regulatory Project Manager, you are reporting to the Head of Regulatory Project and Submission Management who is based in GRA Operations.
Who you are:
- 8+ years’ experience in pharmaceutical industry, with 6 years of regulatory or regulatory operations experience, or equivalent.
- Thorough understanding of the Regulatory Operations area, including processes and technology solutions.
- Demonstrated experience in dossier creation and submission in US and EU.
- Strong project management skills/experience, international project experience.
- High attention to detail and strong organizational skills, work independently, self-motivated and proactive.
- Ability to establish close communications and working relationship with cross functional teams to meet business objectives
- Ability to work with uncertainties and effect innovative solutions to complex regulatory requirements
- Strong negotiating, influencing and interpersonal skills especially regarding indirect people leadership in a matrix organization.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill 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.