Director, Regulatory Strategy & Clinical Development

RXinsider LTD.; Woburn (MA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid work model

Health coverage

401K matching up to 5%

Time off & holidays

Tuition reimbursement

Job summary

Azurity Pharmaceuticals in the United States is seeking a Regulatory Affairs Director – Clinical Strategy to design and lead regulatory strategies for development and commercialization across multiple therapeutic areas.

You will collaborate with Clinical Development, Medical Affairs and Franchise teams to ensure alignment with Health Authority requirements and to guide submissions such as INDs, NDAs and BLAs.

Qualifications

• 10+ years of pharmaceutical industry experience within Regulatory Affairs.
• Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs.
• Experience leading teams and coaching, fostering efficiency and teamwork.
• Ability to adapt to rapidly changing environments while ensuring cGMP and regulatory requirements.
• Strong written and verbal communication skills.
• Bachelor’s degree required; advanced degree preferred.

Responsibilities

• Develop and implement clinical regulatory strategies (MIDD, RWD/RWE, meta-analysis) for pipeline and commercial assets.
• Critically review clinical documents to support regulatory objectives and mitigate risks.
• Support Clinical Development and Medical Affairs with regulatory clinical input.
• Prepare and present regulatory strategy to executives for alignment.
• Demonstrate knowledge of integrated clinical data including efficacy, safety and pharmacokinetics.
• Lead FDA interactions and other health authority meetings.
• Mentor regulatory team and coach on clinical strategy and writing.

Skills

Strong communication

Regulatory knowledge

Leadership experience

Education

Bachelor’s degree in a scientific discipline

MS/PharmD/PhD preferred

Job description

Azurity Pharmaceuticals in the United States is seeking a Regulatory Affairs Director – Clinical Strategy to design and lead regulatory strategies for development and commercialization across multiple therapeutic areas.

You will collaborate with Clinical Development, Medical Affairs and Franchise teams to ensure alignment with Health Authority requirements and to guide submissions such as INDs, NDAs and BLAs.