Senior Director, Regulatory Affairs

The Role:

Reporting to the Chief Medical Officer, the Senior Director of Regulatory Affairs will be responsible for the development and execution of Sails regulatory strategy and operations. This person will lead the development of all relevant regulatory documentation and registration strategies for both the EU and US, bringing credibility and confidence within and outside the organization. The ideal candidate will have experience in Nanoparticle Therapeutics, RNA, or Gene Therapy.

Responsibilities:

• Develop and implement innovative, competitive global regulatory strategies from product inception to end of lifecycle and primary interface with US Food and Drug Administration, overall responsibility for global regulatory strategies. Global Regulatory Leads represent GRA at GPT and lead Global Regulatory Teams (GRTs)
• Provide strategic regulatory input to global teams and regional cross-functional teams for new product filings and business initiatives.
• Responsible for the development of regional regulatory strategies that de-risk and accelerate the registration of innovative and established medicines in the EU; primary interface with EMA.
• 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/strategies for all projects in TA scope (consolidated across JPN, US, EU, and ROW) including ensuring clinical trial requirements for global product approval are met. responsible for growing and developing their function commensurate with the growth and needs of the company.

Qualifications:

• PhD. in Biological sciences (immunology, molecular biology) with 12+ years of relevant experience, or equivalent combination of education and experience
• 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 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.