Director/Associate Director Regulatory Affairs

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.

Requirements

• Bachelor's Degree in clinical, scientific, medical, or industry-related discipline required; Advanced degree (MS, PharmD, PhD) preferred
• Minimum 2–3 years of U.S. regulatory experience
• 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

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
• Strong Microsoft Office skills
• Excellent document writing and formatting
• Experience using regulatory agency submission portals/gateways
• Ability to work independently with minimal oversight
• Strong collaboration skills and team-first mentality

Benefits

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)

Pay

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

Schedule

• Contract to Hire position
• Fully onsite in Durham, NC

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.