Regulatory Affairs Director - REMOTE

Proclinical is seeking a remote Regulatory Affairs Director for a cutting-edge biotech company.

The Regulatory Affairs Director will provide strategic regulatory leadership to advance the development of innovative therapeutic products for neurodegenerative diseases. The successful candidate will report to the Senior Director, Regulatory Affairs and lead regulatory filings and communications for investigational products, which may include monoclonal antibodies and vaccines.

Must be eligible to work in the US.

Job Responsibilities:

• Provide regulatory leadership on project team(s), collaborating with senior leaders and cross-functional team members on development and implementation of regulatory strategies to expedite the development of investigational products consistent with overall program goals and regulatory requirements; anticipate and mitigate strategic risks
• Execute regulatory strategies and perform data assessments to enable timely and effective preparation, review, and submission of key regulatory filings
• Responsible for US regulatory submissions, including original INDs/BLAs, amendments, meeting requests and briefing documents, responses to FDA requests, and maintenance submissions, in collaboration with Regulatory Portfolio Management, Writing and Operations
• Establish and maintain effective ongoing communications with FDA and other Regulatory Agencies, as applicable, for assigned programs

Skills and Requirements:

• At minimum, Bachelor's degree in a scientific discipline; life sciences preferred
• 8+ years of regulatory experience, preferably with at least 10 years in a pharmaceutical or biotechnology company focused on novel therapies; experience with neurodegenerative and rare diseases preferred
• Ability to manage all aspects of regulatory activities from pre-IND through late-stage clinical development; product registration/commercial experience required
• Demonstrated hands-on experience leading preparation, submission, and maintenance of key regulatory filings, in collaboration with project teams and health authority meetings
• Prior FDA regulatory liaison experience required
• Prior experience with neurodegenerative diseases, such as Alzheimer's Disease, a plus

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at +(1) 646-779-7961 or p.huynh@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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