Associate Director, Regulatory Affairs Strategy

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Collaborate closely with core product development teams and subteams to establish and achieve organizational objectives.

• Formulate and ensure effective regulatory strategies and submissions that enhance productivity and efficiency.

• Assist in the implementation of strategic drug development programs through active collaboration.

• Oversee the company’s regulatory programs and product development efforts.

• Manage initial global approvals and post-approval activities for advanced programs in partnership with other companies.

• Supervise and support post-approval maintenance tasks and lifecycle management submissions both in the US and internationally.

• Provide support for development and regulatory projects in the early phases.

• Conduct research on regulations and guidelines to bolster regulatory strategies and regional compliance.

• Compile, prepare, and submit IND, BLA/NDA, as well as other regulatory filings in the US.

• Act as the Global Regulatory Lead for designated projects and deliverables, which includes leading workstreams and participating in clinical study team meetings.

• Monitor regulatory submissions and adjustments in regulatory strategies.

• Assist in coordinating and preparing for meetings with Health Authorities.

• Review, revise, and draft Standard Operating Procedures.

• Manage regulatory timelines and communicate any risks related to timelines or content.

• Keep abreast of current FDA regulations and guidelines concerning INDs and BLAs/NDAs.

• Perform additional duties as required.

⛳️ Requirements

• A Bachelor’s degree is required; an advanced degree (MS, PhD, PharmD) is preferred.

• Eight (8) to ten years of regulatory strategy experience in the biotech or pharmaceutical sector.

• Demonstrated ability to uphold high ethical standards.

• Exceptional organizational skills, keen attention to detail, and strong communication abilities.

• Capability to work collaboratively within a team, both in a leadership capacity for assigned tasks and as a contributing team member.

• Ability to foster and maintain positive working relationships across diverse cross-functional teams.

• Strong interpersonal skills with a proven ability to be an effective and collaborative partner with both internal and external stakeholders.

• Proficient written and verbal communication and presentation skills.

• In-depth understanding of US FDA regulations related to product development (IND/CTA), BLA/NDA/MAA; global experience is an advantage.

• Proficiency in computer applications, including MS Word, MS PowerPoint, and MS Excel.

🏝️ Benefits

• Comprehensive health insurance plans.

• Retirement savings plan with company matching.

• Opportunities for professional development and training.

• Flexible working hours and remote work options.

• Collaborative and inclusive company culture.