Senior Specialist, Regulatory Affairs- CMC:
Merck

REG003526-en_US
Merck
Madison New Jersey
Pharmaceutical
Description
Requisition ID: REG003526

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.
 
The Senior Specialist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Senior Specialist is also responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products.

Responsibilities will include but are not limited to;
  • Work effectively with other functions to manage and prepare regulatory CMC dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country in order to gain new and maintain existing product registrations.
  • Assess post approval changes, provide regulatory filing strategies and timelines, identify risks and propose mitigation strategies.
  • Actively participate on new product development teams as well as other types of teams and initiatives and deliver on all assigned regulatory milestones.
  • Maintain regulatory information in accordance with processes and procedures to support regulatory compliance.
  • Continuously build and share knowledge of CMC related regulations and guidelines (including but not limited to FDA-CVM, EMA, and VICH), authority expectations, as well as current industry standards.
  • Identify and communicate potential regulatory issues to management, as needed. 
Qualifications

Education:
  • Bachelor of Science degree (minimum) in science, engineering, or other relevant field (advanced degree preferred).

Required:

  • A minimum of 2 years of relevant experience (for example: pharmaceutical research, manufacturing, or quality), proficient in English.
  • High level of professionalism, experience reviewing scientific information, demonstrated oral and written communication skills.
  • Demonstrated understanding of related fields (manufacturing, testing, and quality assurance).
  • Leadership skills (problem solver, ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details).

Preferred:

  • Previous experience in a CMC position is preferred.
  • Proficiency in additional languages is a plus.
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

MAH2018


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
Basic Qualifications
Requirement