Associate Director, Regulatory Affairs Strategy

•       Bachelor’s degree required with advanced degree (MS; PhD, PharmD) a plus

•       Eight (8) to ten years regulatory strategy experience in the biotech/pharmaceutical industry.

•       Ability to maintain high ethical standards.

•       Excellent organizational skills, attention to details, and communication skills.

•       Ability to work as part of a team, both in a leadership role on assigned duties and as a contributing member of the company.

•       Ability to develop and maintain positive working relationships across cross-functional teams.

•       Strong interpersonal skills with demonstrated ability to serve as a strong, collaborative partner with internal and external stakeholders and effective written and verbal communication and presentation skills.

•       Thorough knowledge of US FDA regulations, with Global experience a plus, regarding product development (IND/CTA), BLA/NDA/MAA with a sense of curiosity driving continuous learning and program success.

•       Effective written and verbal communication, presentation skills and computer literate (e.g., MS Word, MS PowerPoint, MS Excel).

•       With Director of Regulatory Affairs oversight, this position will manage initial global approvals and global post-approval activities for advanced programs working with partnering companies

•       Manage and support post-approval maintenance activities for marketed products, including lifecycle management submissions in the US and internationally and support development and early-phase regulatory projects as assigned.

•       Support regulatory strategies for assigned projects via researching regulations and guidelines ensuring alignment with regional requirements that will result in the on-time submission and approval of new products.

•       Working with Regulatory Operations, compile, prepare and submit IND, BLA/NDA and additional US regulatory filings as necessary to implement the agreed upon strategy.

•       May serve as the Global Regulatory Lead (GRL) for defined projects and deliverables that may include, and not limited to, leading identified workstreams; attend clinical study team meetings; track and keep reg subteams and program teams current with status of regulatory submissions and any changes in strategies.

•       May support GRL for additional programs on defined workstreams and deliverables including in the coordination and preparation of Health Authority meetings.

•       Review/revise/draft Standard Operational Procedures as required to assure compliance with Global  Regulations and Guidance Documents.

•       Manage regulatory timelines and manage/communicate timeline and/or content risks to Director of Regulatory Affairs Strategist or GRL ensuring that regulatory strategies are executed within those approved timelines.

•       Maintains current with FDA regulations and guidance regarding INDs, BLAs/NDAs, while developing familiarity with global regulations.

•       All other duties as assigned.