Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

The Senior Director, Regulatory Affairs serves as the primary regulatory representative and provides strategic regulatory leadership to cross-functional project teams and sub-teams.

Responsibilities

• Serve as the primary regulatory representative for assigned products and act as the key regulatory point of contact for cross-functional project teams and sub-teams.
• Provide strategic regulatory guidance throughout the product lifecycle, from early development through licensure and post-approval activities.
• Proactively define, assess, and communicate regulatory risks associated with product development programs, and propose mitigation strategies.
• Develop and execute global product regulatory strategies to optimize development timelines, regulatory outcomes, and successful licensure of investigational products.
• Lead the planning, preparation, and coordination of global regulatory submissions, including NDAs and associated amendments or supplements.
• Interpret and apply global regulations, guidelines, and policy statements to ensure compliance and to inform regulatory strategy.
• Leverage expert knowledge of global regulatory landscapes, including requirements in the United States, European Union, and rest-of-world markets, to support worldwide product development.
• Drive regulatory input into clinical development plans, study designs, and key program milestones for global phase III and other clinical studies.
• Collaborate closely with clinical operations, quality, medical writing, and other functions to ensure high-quality, timely regulatory documentation and submissions.
• Monitor evolving regulatory requirements and health authority expectations, and update internal stakeholders on potential impacts to ongoing or planned programs.
• Contribute to the development and maintenance of internal regulatory standards, processes, and best practices to support efficient and compliant regulatory operations.
• Represent regulatory affairs in internal and external meetings, ensuring clear communication of regulatory positions and strategies.

Essential Skills

• Degree in Life Sciences or a related discipline.
• Advanced degree such as PharmD, MSc, PhD, or MD preferred.
• Minimum 10 years of experience working in clinical practice, clinical or basic research, or product development.
• Minimum 10 years of experience in Regulatory Affairs.
• Expert knowledge of global regulatory landscapes and health authority expectations.
• Experience interpreting global regulations, guidelines, and policy statements and applying them to regulatory strategies.
• Experience with multiple approved NDA cycles.
• Experience with regulatory activities in the United States, European Union, and rest-of-world markets.
• Experience and knowledge in the preparation of global regulatory submissions and supportive amendments or supplements.
• Strong ability to provide strategic regulatory guidance to cross-functional teams.
• Proven capability to identify, assess, and mitigate regulatory risks associated with product development.

Additional Skills & Qualifications

• Advanced degree in a Life Sciences discipline (PharmD, MSc, PhD, MD) is highly desirable.
• Background in clinical practice, clinical research, basic research, or product development that supports a deep understanding of drug development.
• Experience working on late-stage development programs, including global phase III studies.
• Ability to work effectively with teams across clinical operations, regulatory, quality, and medical writing.
• Strong communication skills to clearly convey complex regulatory concepts to diverse stakeholders.
• Demonstrated success in leading global regulatory strategies for innovative therapies.

Work Environment

This is a remote position, with a preference for candidates located in Eastern or Central time zones to facilitate collaboration across teams. You will work closely with colleagues in clinical operations, regulatory, quality, and medical writing who support multiple global phase III studies. The organization focuses on late-stage biopharmaceutical development of novel, oral bradykinin B2-receptor antagonists, offering the opportunity to contribute to therapies that aim to provide alternatives to injected treatments for bradykinin-mediated diseases. The work environment emphasizes cross-functional partnership, virtual collaboration, and a strong connection to mission-driven drug development.

This is a Contract to Hire position based out of Lexington, MA.

The pay range for this position is $120.00 - $145.00/hr.

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)

This is a fully remote position.

This position is anticipated to close on Jun 12, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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.

Salary : $120 - $145