Assoc. Director, Regulatory Affairs-CMC, Pharma Post-Approval
Location:
Rahway , New Jersey
Posted:
February 03, 2017
Reference:
REG002758
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Reporting to the Director, the Associate Director is responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, regulatory guidances and Merck procedures. The Associate Director will lead the preparation and submission of CMC dossiers for life-cycle changes to commercial products. Primary responsibilities include, but are not limited to:

Regulatory Responsibilities:
  • Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
  • Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
  • Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
  • Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
  • Collaborate with MMD and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
  • Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
  • Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
  • Assess and communicate potential regulatory risks and propose mitigation strategies.
  • Deliver all regulatory milestones for assigned products across the product lifecycle.
  • Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed.



Qualifications:
Education:
  • Bachelors (advanced degree preferred)
  • B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
  • At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields.
  • The candidate must be proficient in English; additional language skills are a plus.


Required:
  • Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
  • Demonstrated superior oral and written communication skills in multicultural settings and ability to understand and communicate complex issues in a succinct and logical manner.
  • Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.


Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:
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