Top 16 Regulatory affairs manager Jobs in Westborough Ma

Senior Manager, Regulatory Affairs
Kymera Therapeutics —Watertown, MA
- $145,000 - $215,000 a year
- 5 years
- Pediatrics
- Senior level
Quick Apply
Senior Manager, Regulatory Affairs, Operations
Xenon Pharmaceuticals —Needham, MA
- $146,800 - $185,700 a year
- Full-time
- Remote
- Microsoft Word
- 5 years
- Office
- AD&D insurance
- Disability insurance
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Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)
AbbVie —Waltham, MA
- $124,500 - $236,500 a year
- 8 hour shift
- Hybrid work
- Data analysis skills
- Office
- 8 years
- Paid holidays
- Health insurance
Sr Manager, Regulatory Affairs
Alkermes, Inc. —Waltham, MA
- Full-time
- Psychiatry
- Bachelor's degree
- Neurology
Sr. Specialist, Regulatory Affairs
LeMaitre —Burlington, MA
- $110,000 - $150,000 a year
- Full-time
- 5 years
- English
- Bachelor's degree
- Opportunities for advancement
Associate Director Regulatory Affairs – Vascular (on-site)
Abbott Laboratories —Westford, MA
- $129,300 - $258,700 a year
- Full-time
- Management
- 5 years
- Doctor of Philosophy
- Health insurance
- Tuition reimbursement
Senior Regulatory Specialist
Helen of Troy —Marlborough, MA
- $88,743 - $110,929 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Office
- Bachelor's degree
- Paid parental leave
- Paid holidays
Project Manager
InfoQuest Consulting Group Inc. —Waltham, MA
- Email
- 5 years
- Bachelor's degree
- Mentoring
Director or Senior Director, CMC Program Management
Kymera Therapeutics —Watertown, MA
- $195,000 - $330,000 a year
- 11+ years
- Doctor of Philosophy
- Organizational skills
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5d
CMC Operational Planning & Capacity Manager
Sanofi —Framingham, MA
- $122,250.00 - $176,583.33 a year
- Laboratory experience
- Doctor of Philosophy
- Product management
- Parental leave
3d
Vice President, Program Management
Kailera Therapeutics, Inc. —Waltham, MA
- $272,000 - $340,000 a year
- Full-time
- Hybrid work
- 11+ years
- Office
- Continuous improvement
- Commuter assistance
- Paid holidays
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RA Specialist II
Olympus —Westborough, MA
- $91,148 - $123,049 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Paid parental leave
- Paid holidays
Consultant, PAI Inspection Readiness
Syner-G —Northbridge, MA
- Hybrid work
- Office
- Residential
- Master's degree
- Paid holidays
- Paid time off
Quick Apply
12d
Project Manager
AmNet Services, Inc. —Westborough, MA
- Contract
- Mid-level
Quick Apply
Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist
CSL Behring —Waltham, MA
- Full-time
- 5 years
- Office
- Analysis skills
4d

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Senior Manager, Regulatory Affairs

Kymera Therapeutics
Watertown, MA

Quick Apply

Job Details

$145,000 - $215,000 a year

Qualifications

Clinical development
Pharmaceutical company experience

Full Job Description

Who we are:

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston's top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.

How we work:

PIONEER: We are courageous, resilient and rigorous in our mission to improve patients' lives through our revolutionary degrader medicines.
COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you'll make an impact:

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.

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.

Skills and experience you'll bring:

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).
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.

Equal Employment Opportunity

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Compensation

Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
The anticipated base salary range for this role is $145,000 – $215,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate's depth of experience and the capabilities they bring to the position.

Quick Apply

Refine Your Search

regulatory affairs manager jobs in westborough ma

Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs, Operations

Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)

Sr Manager, Regulatory Affairs

Sr. Specialist, Regulatory Affairs

Associate Director Regulatory Affairs – Vascular (on-site)

Senior Regulatory Specialist

Project Manager

Director or Senior Director, CMC Program Management

CMC Operational Planning & Capacity Manager

Vice President, Program Management

RA Specialist II

Consultant, PAI Inspection Readiness

Project Manager

Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist

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