Sr. Specialist, Regulatory Affairs-CMC (Biologics)

West Point, PA, US
October 12 2017
Organization Type
Requisition ID: REG003213

Under the guidance of a Global Regulatory Affairs - CMC Director, the Senior Specialist will work within a team to lead and execute change control assessments, develop and execute regulatory strategies, plan, track, author, review and gain approval for global post approval changes.

The Senior Specialist responsibilities include but are not limited to:
•Participation in the authorization process to prioritize submissions.
•Knowledge of global CMC guidelines regarding post approval changes.
•Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines.
•Development and execution of detailed, global regulatory strategies for submission and approval of post approval change documentation according to defined timelines.
•Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
•Lead authoring of clear, concise and effective global post approval submissions according to defined timelines.
•Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
•Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.
Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required.Qualifications

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.

Education Minimum Requirement:
  • Bachelor’s degree in Biology, Chemistry, Engineering, or a related discipline
Required Experience and Skills:
  • Proficient in M.S. Word
  • Adept at use of assessment, planning and tracking systems
  • Capability to work effectively in matrix organizational structures
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
Preferred Experience and Skills:
  • Experience with post approval changes in Biologics or Vaccines

If you need an accommodation for the application process please email us at

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:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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