Director, Regulatory Affairs CMC

About Generate Biomedicines

Generate Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. Generate has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate was founded in 2018 by Flagship Pioneering and has received over $420 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with over 200 employees.

The Role:

We are seeking a highly motivated and experienced individual for a Director position in Global Regulatory Affairs CMC. The successful candidate will work in close collaboration with the Regulatory Affairs, Clinical Development and the CMC and Quality organization as part of cross-functional teams. The candidate will develop, implement, and coordinate all aspects of global CMC regulatory strategy to support the continued development of Generate Biomedicine’s therapeutics through licensure and beyond.  The successful candidate will monitor US, EU, and other regional regulatory CMC requirements and CMC regulatory commitments.

Key Responsibilities:

• Lead and execute key regulatory CMC activities, including planning, writing, and reviewing of documents necessary to support regulatory submissions, including INDs, IMPDs, CTAs, BLAs, MAAs, and their supplements/variations, meeting requests, briefing packages, and responses to queries from regulatory agencies.
• Manage and implement planning, authoring and submission of high-quality CMC‑related sections of briefing documents and clinical trial applications in the US, EU and ROW
• Develop and establish regulatory CMC processes and procedures and provide training to other departments.
• Communicate and negotiate with international Health Authorities, directly and indirectly
• Ensure that overall project timelines support the coordination and preparation of timely submissions.
• Communicate and coordinate with relevant functional groups and project team members to identify and ensure the preparation of required CMC documentation and data needed for regulatory submissions.
• As a member of program teams, you will provide strategic CMC regulatory advice, communicate regulatory risks, and manage CMC submissions/communications with health authorities
• Support negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections
• Stay up-to-date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share experience with others to support their development
• Act as global regulatory CMC lead for assigned development programs of a therapeutic and define and execute Regulatory CMC Strategy from pre-clinical stage up to (including) Marketing Authorization
• Work in collaboration with project teams to provide strategic regulatory guidance for licensure and beyond.
• Oversee/manage regulatory CMC consultants as needed
• Present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment and providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.
• Serve as a technical and scientific resource and provide guidance for completion of difficult and complex projects.

Qualifications:

• Demonstrated experience in the preparation, submission, and maintenance of CMC regulatory filings in collaboration with project teams, including original BLA/MAA, INDs/CTAs, amendments, and Scientific Advice
• Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up or regulatory registration of products is required
• Experience with global regulatory aspects of CMC involving undefined frameworks with medium technical complexity and defined scope
• Dire