Global Regulatory CMC Manager

Global Regulatory CMC Manager – Contract – Princeton, NJ - $90.00-$100.00/hr
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Global Regulatory CMC Manager in Princeton, NJ.

Role Description

• Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
• Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
• Responsible for the global regulatory evaluation of CMC change controls with supervision.
• Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
• Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
• Participate in global regulatory interactions with health authorities, with supervision.
• Facilitate document review meetings and discussions.
• Develop and maintain knowledge of regulatory environment, regulations and procedures.

Skills & Requirements

• 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience
• Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
• Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
• Experience in drug development processes and post-approval requirements
• Experience in developing CMC regulatory strategy
• Experience in project management
• Have a solution-oriented approach to problem solving
• Ability to plan/prioritize work of group members and guide/develop others.
• Ability to work on complex projects and within cross-functional teams with supervision
• Excellent communication skills, both written and oral

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information. #1133053

Summary

Job Type
Contract
Industry
Pharmaceuticals
Location
Princeton
Specialism
Pharma
Pay
$90.00-$100.00/hr
Ref:
1133053

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