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- Provides regulatory guidance and strategy for gene therapy programs, including assessing and identifying regulatory risks
- Manages activities with emphasis on regulatory strategy preparation, review and submission of documents for FDA (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) and other regulatory authorities
- Critically reviews and provides input on all regulatory filing documents
- Leads and facilitates activities, including team preparation, for meetings with FDA and other regulatory authorities for development activities
- Functions as liaison responsible for communicating with FDA and other regulatory authorities
- Identifies issues and develops appropriate regulatory strategies to mitigate risks to filings
- Ensures stakeholders are informed of developments that may affect regulatory success
- Performs compliance functions within the company
- Coordinates and manages regulatory inspections as needed
- Stays current with emerging legislation and guidance in the field and contributes to ensuring company-level awareness and compliance
- Bachelor's degree in a science related field
- At least ten years of biopharma experience with five years of relevant regulatory experience at a leadership level in the field of gene therapy. Experience with virus manufacturing a plus.
- Understanding of molecular biology techniques related to gene therapy
- Direct experience interacting with FDA and other regulatory authorities
- Excellent verbal and written communication skills
- Excellent organizational skills and attention to detail
- Excellent time management skills with a proven ability to meet deadlines
- Ability to develop and maintain strong relationships critical to a team-based environment
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
Associate Director Regulatory Affairs - Rochester, United States - Vyriad Inc
Description
The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriad's gene therapy product development, registration, and post-approval strategies.
The position will be responsible for crafting and assuring development and execution of regulatory strategies for biological drug products and combination products globally, providing direction on the interpretation and application of global CMC regulations and guidance related to gene therapy.
The position will also manage contract regulatory support in the performance of duties outlined below.Supervisory responsibilities
Contract regulatory support as necessary.
Duties and Responsibilities