Regulatory Affairs Manager

Proclinical is currently recruiting for a Regulatory Affairs Manager with a pharmaceutical company located in Oceanside, CA.

Job Responsibilities:

• Responsible for preparing and submitting complex regulatory documents which require interaction with departments outside of Regulatory Affairs CMC for investigational, primarily biologic, products, in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Examples include original INDs and BLAs, amendments, supplements, annual reports and license renewals.
• May provide strategic Regulatory CMC advice as appropriate. Provides input to senior Regulatory Affairs CMC professionals in the preparation of country specific labeling and for ensuring product packaging and associated information is included in regulatory submissions or updated and maintained in accordance with the product licenses, as applicable.
• Maintains knowledge of regulatory requirements and communicates changes in regulatory information to Regulatory project teams in a timely manner.
• Work cooperatively with regional regulatory sites to support the accurate and timely communication of critical information. Provide support for cGMP activities as they relate to regulatory affairs.
• Work is performed cross-functionally within a matrixed organization under limited direction of a senior Regulatory Affairs CMC professional and line manager.

Skills and Requirements:

• Requires a bachelor's degree (scientific field preferred)
• 5-7 years of relevant experience in Regulatory Affairs CMC for biologics. Experience with BLA submissions desired.
• Excellent organizational skills and ability to work on several projects with tight timelines is required.
• Excellent verbal and written communication skills and interpersonal skills are expected.
• Must work well under demanding deadlines and have excellent attention to detail.

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.

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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