Regulatory Operations Manager / Senior Manager*
This part-time Regulatory Operations Manager / Senior Manager role supports global regulatory activities for innovative biopharma development programs. You will work within the Regulatory Affairs team and closely collaborate with Clinical Development, Clinical Operations, Technical Operations, Nonclinical, and Legal to deliver high-quality regulatory submissions and advance a pipeline focused on immunological and inflammatory disorders. This position offers the opportunity to contribute to cutting-edge, genetics-informed precision medicine and antibody development in a dynamic, fast-paced environment.
Responsibilities
Support global regulatory activities for development programs across multiple regions.
Prepare, coordinate, and manage high-quality regulatory submissions, including INDs and CTAs.
Partner closely with cross-functional stakeholders in Clinical Development, Clinical Operations, Technical Operations, Nonclinical, and Legal to plan and execute regulatory deliverables.
Ensure regulatory submissions comply with US and international regulatory requirements for drug development.
Coordinate and oversee regulatory operations aspects of submissions, including timelines, documentation, and tracking.
Manage and collaborate with external vendors involved in regulatory submissions and related activities.
Contribute to the implementation and continuous improvement of regulatory operations processes, tools, and standards.
Support the advancement of the development pipeline by providing operational regulatory input to project teams.
Communicate clearly and proactively with internal teams regarding submission status, requirements, and key milestones.
Operate effectively in a self-motivated, fast-paced, start-up environment while maintaining high-quality standards.
Essential Skills
Bachelor's degree in a scientific or healthcare discipline.
At least 2 years of experience in Regulatory Operations within a biopharma setting.
Strong knowledge of US and international regulatory requirements for drug development.
Hands-on experience with regulatory submissions, including IND and CTA filings.
Experience with vendor management in the @context of regulatory operations or submissions.
Excellent verbal and written communication skills.
Strong organizational skills with the ability to manage multiple priorities and deadlines.
Proven ability to collaborate effectively across functions such as Clinical Development, Clinical Operations, Technical Operations, Nonclinical, and Legal.
Demonstrated success working in a self-motivated, fast-paced environment, ideally within a start-up or similar setting.
Additional Skills & Qualifications
Experience in Regulatory Affairs Operations specifically within biopharma.
Familiarity with precision medicine and antibody-based drug development.
Interest in or exposure to immunological and inflammatory disorders.
Ability to contribute to process improvements in regulatory operations.
Comfort working in a growing organization that is pioneering new scientific approaches.
Work Environment
This is a part-time position of approximately 20 hours per week, Monday through Friday, in a hybrid work arrangement. The role requires being local to Massachusetts to enable on-site collaboration as needed. You will work in a fast-paced, start-up style biopharma environment focused on genetics-informed precision medicine and functional antibody development for immunological and inflammatory disorders. The culture emphasizes cross-functional collaboration, scientific innovation, and a strong sense of purpose in developing meaningful treatment options for patients.
Job Type & Location
This is a Contract position based out of Watertown, MA.
Pay and Benefits
The pay range for this position is $70.00 - $75.00/hr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Watertown,MA.
Application Deadline
This position is anticipated to close on Aug 21, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
