Regulatory Affairs Manager CMC

Proclinical is seeking a Regulatory Affairs Manager CMC for a leading biopharmaceutical company located in Redwood City, CA.

Must be eligible to work in the US.

Job Responsibilities:

• Responsible for regulatory input and support for CMC collaboration with other project team members, including other regulatory team members.
• Contributes to the development of CMC regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
• Prepares and/or manages CMC submissions that may be technically complex and require extensive interaction with departments outside of regulatory affairs.
• Maintains knowledge of regulatory requirements up to current date and communicates changes in regulatory information to other departments.
• Work is performed under the direction of a Senior Regulatory Affairs professional.

Skills and Requirements:

• A degree in a life science, chemistry, or chemical engineering or closely related discipline with a graduate degree preferred and 4 years of experience in pharmaceutical / biotechnology regulatory affairs. Strong track record of contributing to regulatory submissions would be considered.
• Experience in a small company and in a fast-paced environment is preferred.
• Proven proficiency in MS Word, Excel, Power Point, Visio, Adobe Acrobat. Must have experience with document formatting templates.
• Regulatory experience development of modified-release solid oral dosage forms is highly preferred, and regulatory experience in the development of small molecules is required.
• Working knowledge of US regulations and relevant guidelines (e.g., FDA, ICH, etc.).
• Excellent verbal, written, negotiation and interpersonal skills are required. Must be articulate and able to communicate effectively both orally and in writing with employees at all levels of the global organization and external audiences.

If you are having difficulty in applying or if you have any questions, please contact Lauren Banks at +(1) 929-244-2402 or l.banks@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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