Senior Manager, Regulatory Affairs

Kymera Therapeutics•Watertown, MA

4d•$145,000 - $215,000

About The Position

Kymera Therapeutics is seeking a Senior Manager, Regulatory Affairs to serve as a key regulatory contributor and emerging strategic leader across multiple drug development programs. Reporting to the Director of Regulatory Affairs, the Senior Manager will independently lead regulatory activities at the study level, acting as the regulatory representative on cross-functional teams while driving execution of program regulatory strategies. This is a high visibility, dynamic role for a highly motivated regulatory professional ready to take on increasing autonomy and ownership in a fast-growing biotech environment.

Requirements

A minimum of 5–7 years of drug development experience in regulatory affairs, with demonstrated progression in roles and responsibilities.
Demonstrated experience independently managing and overseeing regulatory submissions (INDs/CTAs, amendments, designation requests).
Experience representing Regulatory Affairs on cross-functional study teams.
Bachelor’s degree in a scientific discipline; advanced degree preferred but not required.
Strong working knowledge of drug development processes and US regulatory requirements; familiarity with global regulatory frameworks a plus.
Knowledge and understanding of EU CTR and experience with CTIS submission processes.
Excellent verbal and written communication skills, with an ability to write clearly and concisely as well as present information and ideas effectively to cross functional teams.
Strong critical thinking, prioritization, and problem-solving skills; self-starter able to manage multiple priorities in a fast-paced environment.
Collaborative team player able to work efficiently within the regulatory group, cross-functionally, and with internal and external counterparts.

Nice To Haves

Ideally has experience in immunology or gastroenterology drug development

Responsibilities

Serves as the regulatory representative on study-level cross-functional teams, providing regulatory guidance and ensuring alignment with program objectives
Independently leads the compilation, authoring, and completion of regulatory submission packages, driving submissions from initiation through filing, including for initial CTAs and INDs and amendments
Provides oversight and maintains partnership with CRO regulatory groups supporting assigned programs.
Reviews regulatory packages as part of the drug release process.
Drafts and generates designation requests and regulatory applications (e.g., Orphan Drug, Fast Track, Breakthrough Therapy) for assigned programs.
Supports the planning, preparation, and execution of health authority interactions, including FDA meetings, scientific advice procedures, and other agency engagements; contributes to briefing documents, meeting requests, responses to regulatory questions, and other regulatory communications.
Evaluates regulatory precedent, guidance, and competitive intelligence to inform regulatory recommendations and development planning, including assessments related to development pathways, expedited programs, pediatric requirements, and regional filing considerations.
Maintains current awareness of the external regulatory environment, including new guidance documents, legislation, and precedents relevant to Kymera’s therapeutic areas, and disseminates insights to cross-functional stakeholders.
Contributes to defining and implementing standard processes and best practices for the Kymera regulatory group.