Regulatory Affairs Associate Director or Senior Manager

Regulatory Affairs Associate Director or Senior Manager

This biopharmaceutical company is acquiring, developing, and commercializing innovative therapies for patients with rare diseases. They are seeking an Associate Director of Regulatory Affairs (or Senior Manager) to manage day-to-day Global Regulatory activities for development and commercial pharmaceutical programs. Reporting into the VP of Regulatory & Quality, you will support global regulatory strategy implementation and prepare regulatory submissions. This company offers hybrid work arrangements, excellent employee benefits, and a tight-knit company culture. With two approved products and another application currently under Priority Review by FDA, now is an exciting time to join this growing organization!

Base pay range

$130,000.00 / yr - $200,000.00 / yr

Responsibilities

• Support global regulatory strategy and manage activities for a portfolio of Rare Disease programs.
• Respond to FDA queries and support Health Authority interactions.
• Support the compilation, review and / or filing, and maintenance of regulatory applications for US, EU, GB, and other applicable territories.
• Coordinate and / or contribute by authoring and reviewing submission documents such as DSURs, PADERs, PBRERs, annual reports, variations, supplements and amendments as needed.
• Maintain all regulatory logs (filings, communications, submission calendars, etc.).
• Maintain applicable Regulatory licenses (U.S. State licenses, manufacturing, and distribution, etc.).
• Develop and manage project timelines for regulatory submissions.
• Coordinate with all internal and external contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission.
• Implement or maintain regulatory affairs policies and procedures to ensure regulatory compliance.
• Tracks submissions, correspondence, and commitments with regulatory agencies.
• Write and / or maintain standard operating procedures, department working practices, templates and style guides, as appropriate.
• Provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality, and meets eCTD submission requirements.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies and to ensure that appropriate regulatory agency requirements are met.
• Ensure accurate retention in the archival system of all regulatory submissions and contacts with health authorities.

Qualifications

This is a hybrid position in the Greater San Diego area, and applicants must be in the office three days per week. Our client can provide relocation support for the right candidate.

Please note that our client is not able to support H1B or TN transfers.

Position details

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