Director/Associate Director Regulatory Affairs

Job Title: Director/Associate Director Regulatory Affairs

Job Description

Contribute to the development and oversee the implementation of global regulatory strategies for assigned programs in alignment and compliance with local and regional requirements and company policies. Ensure effective communication with business partners and representatives of regulatory authorities worldwide, including planning and leading meetings with regulatory authorities.

Responsibilities

• Oversee and provide direct input to global regulatory submissions for projects in early and late-stage development, including submission of high-quality INDs, CTAs, BLAs/MAAs, meeting packages, responses to requests for information, amendments, and required elements such as safety reports and annual reports.
• Provide regulatory strategic input for global drug development projects, including but not limited to regulatory requirements, opportunities for expedited development, and timing and content of agency interactions to support successful development programs.
• Lead the preparation of regulatory submissions, ensuring the planning, coordination, preparation, and review of all submissions to global regulatory authorities.
• Interpret and communicate regulatory expectations to stakeholders to execute program objectives in compliance with applicable regulations.
• Maintain an awareness and apply a comprehensive understanding of relevant regulations and guidelines to enhance the probability of regulatory success and compliance.
• Ensure that company and project team objectives and timelines are supported by regulatory deliverables.
• Provide de-risking development strategies and evaluate opportunities to accelerate development in a fast-paced environment.
• Represent Regulatory Affairs on global project teams, sub-teams, and external alliances as needed.
• Provide support to clinical study-related activities, including interacting with CROs as needed.
• Contribute to the development of policies, procedures, and best practices in a rapidly growing company.
• Work as a member of a team, fostering constructive working relationships with internal and external colleagues.

Essential Skills

• Global Regulatory Strategy
• Regulatory Submissions
• FDA Compliance
• ICH Guidelines
• Biologics Drug Development
• Experience with Global Phase II or Phase III clinical trials
• Experience owning or supporting INDs
• CTA experience
• Biologics experience
• Strong Microsoft Office skills
• Excellent document writing and formatting
• Experience using regulatory agency submission portals/gateways
• Minimum 2-3 years of U.S. regulatory experience
• Ability to work independently with minimal oversight
• Strong collaboration skills and team-first mentality

Additional Skills & Qualifications

• Bachelor"s Degree in clinical, scientific, medical, or industry-related discipline required; Advanced degree (MS, PharmD, PhD) preferred
• Experience with biologics drug development
• Experience with autoimmune disease, especially inflammatory bowel disease drug development
• Hands-on experience with CMC regulatory strategy and documents for a biological product
• Scientific experience in immunology, cell biology
• Experience in both early and late-stage drug development
• Recent experience with BLA, NDA, MAA

Work Environment

This position requires working on-site. The opportunity for professional growth is abundant as programs are complex and may involve multiple indications, combination therapies, drug-device combinations, companion diagnostics, and expedited regulatory pathways. The work environment is collaborative and fast-paced, providing a dynamic atmosphere for career development.

Job Type & Location

This is a Contract to Hire position based out of Durham, NC.

Pay and Benefits

The pay range for this position is $90.00 - $120.00/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)

Workplace Type

This is a fully onsite position in Durham,NC.

Application Deadline

This position is anticipated to close on Jul 31, 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.