Senior Manager Global Regulatory Affairs CMC (GRA-CMC)

Posted 01 Mar 2019

Billerica, Massachusetts - United States

Req Id 188888

Details

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.


Your role:

  • Lead and drive global CMC regulatory strategy for the assigned products in target regions. This encompasses responsibility for the CMC section of the Regulatory Strategy Document, risk assessment, strategic support and advice.
  • Provide support to the GRL/MPL during Health Authority interactions on CMC issues.
  • Be accountable for the global strategy and plan for dossiers related to the assigned projects. Examples for these dossiers comprise clinical trial applications, answers to Health Authority queries, life cycle management submissions, marketing authorization applications, briefing documentation for Health Authority interactions.
  • Be accountable and responsible to provide country specific CMC regulatory requirements for dossier strategies and plans in close collaboration with other GRA functions. This includes assessment of Change Control Proposals for their regulatory impact worldwide to ensure that for each change control proposal, the regulatory implications have been considered.
  • Review study protocols and reports, as well as other relevant technical documents intended for the product documentation platform or for local submission to confirm alignment of the report conclusions with the CMC Dossier Strategy and Plan. Be accountable for CMC dossier approval.
  • Be accountable to track submission and approval status to ensure regulatory compliance for all CMC dossier submissions worldwide.

Who you are 

  • Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
  • 7+ years of biopharmaceutical industry experience, with at least 3 years of global CMC regulatory experience
  • Ability to develop and prepare successful regulatory strategies and dossiers
  • In-depth knowledge of global pharmaceutical legislation
  • Excellent written and spoken communication skills in English


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.

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