Senior Manager, Global Regulatory Affairs CMC (GRA-CMC)
Company: EMD Serono
Posted on: October 13, 2019
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.
* 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
* 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
Who you are
* Degree in a Life Science or related discipline (minimum MSc or
equivalent degree), higher degree preferable (e.g. PhD in a
* 7+ years of biopharmaceutical industry experience, with at least
3 years of global CMC regulatory experience
* Ability to develop and prepare successful regulatory strategies
* 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 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
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.
Keywords: EMD Serono, Boston , Senior Manager, Global Regulatory Affairs CMC (GRA-CMC), Executive , Billerica, Massachusetts
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