Regulatory Affairs Manager

Regulatory Affairs Manager / Senior ManagerThis role supports global regulatory activities for innovative development programs within a dynamic biopharma environment. Reporting to the Senior Director of Regulatory Affairs, you will help drive high-quality regulatory submissions and contribute directly to the advancement of a pipeline focused on novel, genetics-informed precision medicines for immunological and inflammatory disorders.ResponsibilitiesSupport global regulatory activities across multiple development programs, ensuring alignment with applicable US and international regulatory requirements.Prepare, coordinate, and contribute to high-quality regulatory submissions, including IND and CTA filings, amendments, and related documentation.Partner closely with cross-functional stakeholders, including Clinical Development, Clinical Operations, Technical Operations, Nonclinical, and Legal, to ensure cohesive regulatory strategies and timely submissions.Manage and collaborate with external vendors to support regulatory operations, ensuring deliverables meet quality, compliance, and timeline expectations.Contribute to the planning and execution of regulatory strategies that support the advancement of the company's pipeline, including programs targeting immunological and inflammatory disorders.Maintain up-to-date knowledge of evolving regulatory guidelines and expectations, and help translate these requirements into practical processes and documentation.Organize, track, and maintain regulatory documentation and correspondence to support inspections, audits, and internal reviews.Communicate clearly and proactively with internal teams regarding regulatory timelines, risks, and requirements, fostering effective cross-functional collaboration.Work independently in a fast-paced, start-up environment, prioritizing multiple projects and deadlines while maintaining high standards of accuracy and compliance.Essential SkillsBachelor's degree in a scientific or healthcare discipline.At least 2 years of experience in Regulatory Affairs or Regulatory Affairs Operations within a biopharma setting.Strong knowledge of US and international regulatory requirements for drug development.Hands-on experience with regulatory submissions such as IND and CTA filings.Vendor management experience in a regulatory or related operational context.Excellent verbal and written communication skills, with the ability to convey complex regulatory information clearly.Strong organizational skills and attention to detail, with the ability to manage multiple projects simultaneously.Proven ability to collaborate effectively with cross-functional teams, including 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 growth-stage biopharma company.Additional Skills & QualificationsExperience supporting regulatory strategies for programs in immunology, inflammatory disorders, or related therapeutic areas.Familiarity with precision medicine approaches and genetics-informed drug development.Interest in or exposure to antibody-based therapeutics and biologics development.Comfort working within evolving processes and structures typical of a high-growth organization.Ability to build strong working relationships with internal and external stakeholders and adapt communication style to diverse audiences.Work EnvironmentThis position operates in a hybrid work model, requiring local presence in Massachusetts. The role involves approximately 20 hours per week, Monday through Friday, providing flexibility while maintaining regular collaboration with the broader team. You will work within a fast-paced, start-up biopharma environment focused on cutting-edge, Mendelian genetics-informed precision medicine and functional antibody development for immunological and inflammatory disorders. The culture emphasizes innovation, cross-functional partnership, and scientific rigor, with regular interaction across Clinical Development, Clinical Operations, Technical Operations, Nonclinical, and Legal teams. Work is primarily office and computer-based, with a strong emphasis on documentation quality, regulatory compliance, and effective virtual and in-person communication.Job Type & LocationThis is a Contract position based out of Watertown, MA.Pay and BenefitsThe 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 TypeThis is a hybrid position in Watertown,MA.Application DeadlineThis position is anticipated to close on Aug 28, 2026.