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Senior Specialist, Regulatory CMC Biologics

Requisition ID: REG003836

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its¬ legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


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Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.¬ 


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Position Description:



  • Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products. Be accountable for the delivery of all regulatory milestones through product development.

  • Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory CMC requirements and identification of potential risks.

  • Manage execution of CMC documentation including IND/IMPD, original BLA/MAA, agency background packages and responses to health authority questions per established business processes and systems.¬ 

  • Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management, as needed

  • Conduct all activities with an unwavering focus on compliance


Qualifications

Education Minimum Requirement:




  • B.S.



Required Experience and Skills:¬ 




  • 5+ years of CMC related experience



Preferred Experience and Skills:




  • Experience in biologics CMC preferred



Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.¬ 


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If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.


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Search Firm Representatives Please Read Carefully:¬ 


Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.¬  Please, no phone calls or emails.¬  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.¬  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.


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For more information about personal rights under Equal Employment Opportunity, visit:


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¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ EEOC Poster


¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ EEOC GINA Supplement¬ 


Job: Regulatory Affairs - CMC
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 2
Shift (if applicable): N/A
Hazardous Materials: None
Company Trade Name: Merck

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