Senior Manager, Regulatory Affairs

About Sail:

The Role:

Reporting to the Chief Medical Officer, the Senior Manager of Regulatory Affairs will be responsible for the development and execution of Sails regulatory operations and the planning, managing and tracking of regulatory submissions. This person will lead the development of all relevant regulatory documentation, registration, and submission for both the EU and US, acting as the primary POC and provide operational expertise to cross-functional submission teams across the organization. Experience in Nanoparticle Therapeutics, RNA, Cell Therapy, or Gene Therapy is required.

Responsibilities

• Responsible for the development of regional regulatory operations that de-risk and accelerate the registration of innovative and established medicines for both US and OUS regulatory agencies.
• Flawless execution of global registration strategies that enhance the likelihood of regulatory approval through the pursuit of novel regulatory pathways and continuous sponsor/regulatory dialog in support of EU and US business priorities.
• Identify regulatory requirements and trends across therapeutic areas of responsibility, and provide regulatory guidance, and expertise to the global development team and/or higher governance bodies in these areas.
• Responsible for global regulatory development plans for all projects in TA scope (consolidated across JPN, US, EU, and ROW) including ensuring clinical trial requirements for global product approval are met.
• Manage the development and maintenance of a submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and QC.
• Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed.
• Provide operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (BLA, NDA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.

Qualifications:

• BS with 8+ years of industry experience (or equivalent combination of education and experience) with at least 5+ years in regulatory affairs.
• Submission experience with Nanoparticle based therapeutics, RNA, or Gene Therapy
• Expert knowledge of relevant FDA, EU, and ICH guidelines and regulations
• Experience as a primary regulatory author for IND, BLA and CTA documents.
• Strong experience with CTD format and content regulatory filings. Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide development teams in building appropriate global regulatory strategies.
• Must have the proven ability to advise senior & matrixed leaders effectively.
• Must have superior interpersonal and organizational skills, along with a demonstrated. ability to think strategically and critically and consistently exercise sound judgment.
• Proven track record of coordinating multiple programs simultaneously, moving projects forward, and developing and implementing creative, solution-oriented strategies while anticipating future demands and opportunities.