Sr. Specialist, Regulatory Affairs, CMC - Post Approval

Date: Jul 19, 2018

Location: West Point, PA, US

Requisition ID: REG003540

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.


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. 


Position Summary:


Reporting to the Associate Director, the Sr. Specialist is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies.  The Senior Specialist is responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products.  Primary responsibilities include, but are not limited to:


Regulatory Responsibilities:

  • Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify 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.   
  • Liaise with MMD and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
  • Assess and communicate potential regulatory risks and propose mitigation strategies.
  • Deliver all regulatory milestones for assigned products across the product lifecycle
  • Identify and communicate potential regulatory issues to GRACS CMC management, as needed
Qualifications


Education  Requirement:
  • 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.
Required Experience and Skills:
  • At least two (2) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing or a related field. 
  • The candidate must be proficient in English; additional language skills are a plus.
Technical Skills:
  • Experience in reviewing 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 oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
  • Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance). 
Leadership Skills:
  • Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
  • Capability to handle multiple priorities and balance work to achieve business goals.
  • Demonstrated effective leadership, communication, and interpersonal skills. on business commitments and project timelines.
Preferred Experience and Skills:
A candidate with experience in CMC post-approval lifecycle management and strong API expertise is 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. 

 

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.

  

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.

 

Visa sponsorship is not available for this position.

 

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

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Regulatory Affairs - CMC
Other Locations: Rahway, NJ, US
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck


Nearest Major Market: Philadelphia