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Sr. Specialist, Regulatory Affaris - Biologics CMC

Merck


Location:
West Point, PA
Date:
08/17/2017
2017-08-172017-09-16
Job Code:
REG003041
Merck
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Job Details

Job Title: Sr. Specialist, Regulatory Affaris - Biologics CMC  - REG003041

Description

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. 

 

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

Education:

  • Bachelor’s degree in Biology, Chemistry, Engineering, or a related discipline

Required:

  • At least two (2) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing or a related field.
    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 with post approval changes in Biologics or Vaccines

 

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 an accommodation for the application process please email us at 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.

 

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

 

            

            



Job Regulatory Affairs - CMC

Primary Location NA-US-PA-West Point

Other Locations NA-US-NJ-Kenilworth

Employee Status Regular

Number Of Openings 1

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