Regulatory Affairs Manager

Actalent; Deutschland; Hybrid; EUR 83.000 - 89.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) retirement plan

Life Insurance

Paid time off

Zusammenfassung

Actalent in Watertown, MA seeks a Regulatory Affairs Manager to support global regulatory activities, prepare and coordinate IND/CTA filings, and work with clinical development, operations, and legal to ensure timely submissions in a hybrid, startup-like setting.

The role requires 2+ years in regulatory affairs within biopharma, strong knowledge of US/international requirements, and vendor management experience. Hybrid work, approx. 20 hours/week in MA.

Qualifikationen

• Bachelor's degree in a scientific or healthcare discipline.
• At least 2 years of Regulatory Affairs or Operations experience in biopharma.
• 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 with cross-functional teams (Clinical Development, Clinical Operations, Technical Operations, Nonclinical, Legal).
• Experience thriving in a fast-paced, startup-like biopharma environment.

Aufgaben

• Support global regulatory activities across development programs with US and international requirements.
• Prepare, coordinate, and contribute to regulatory submissions including IND/CTA filings.
• Partner with Clinical Development, Clinical Operations, Technical Operations, Nonclinical, and Legal to align regulatory strategies.
• Manage external vendors to meet quality, compliance, and timelines.
• Contribute to regulatory strategies supporting immunology/inflammatory programs and precision medicine.
• Maintain up-to-date knowledge of evolving regulatory guidelines and translate into practical processes.
• Organize and maintain regulatory documentation for inspections, audits, and reviews.
• Communicate timelines, risks, and requirements to internal teams to enable cross-functional collaboration.
• Work independently in a fast-paced startup biopharma environment.

Kenntnisse

Regulatory submissions

IND/CTA filings

Vendor management

Cross-functional collaboration

Regulatory strategy

Regulatory compliance

Written and verbal communication

Multi-project management

Startup environment

Ausbildung

Bachelor's degree in science/healthcare

Jobbeschreibung

Job Title: Regulatory Affairs Manager / Senior Manager

Job Description

This 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.

Responsibilities

• Support 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 Skills

• Bachelor'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 & Qualifications

• Experience 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 Environment

This 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 & 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 28, 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 [e-mail] 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.