Director, Regulatory Affairs (US Market)

About Us

Friday Plansis a technology-driven US-based company evolving from a leading online pharmacy into a vertically integrated pharmaceutical company. Our mission is to develop, manufacture, and commercialize our own portfolio of medicines for the US market. We are seeking a seasoned regulatory leader to navigate this journey and build our regulatory function from the ground up.

Position Summary

We are looking for a strategic and hands-on Director of Regulatory Affairs to lead all regulatory activities for our product portfolio targeting the US market. This individual will be responsible for developing and executing the regulatory strategy for our pipeline, from early development through to post-approval life cycle management. You will serve as our primary expert on US FDA regulations, manage the preparation and submission of high-quality regulatory dossiers (ANDAs/NDAs), and act as the primary point of contact with health authorities.

Key Responsibilities

Regulatory Strategy:

• Develop and implement innovative and effective regulatory strategies for the timely approval of our products in the US.
• Provide expert regulatory guidance to cross-functional teams, including R&D, Clinical, and Technical Operations, throughout the product lifecycle.
• Conduct regulatory intelligence and risk assessments to inform product development and company strategy.

Submissions and Dossier Management:

• Lead the planning, authoring, and review of all regulatory submissions, including Investigational New Drug applications (INDs), Abbreviated New Drug Applications (ANDAs), and New Drug Applications (NDAs).
• Ensure all dossiers are high-quality, compliant with eCTD format, and submitted on schedule.
• Manage responses to inquiries and information requests from the US FDA and other regulatory agencies.

Health Authority Interaction:

• Serve as the primary liaison between the company and the US FDA.
• Lead the preparation for and conduct of key meetings with regulatory authorities.

Compliance and Labeling:

• Review and approve all product labeling, advertising, and promotional materials for regulatory compliance.
• Ensure company-wide adherence to cGMP/GCP regulations and internal quality standards.
• Oversee post-approval activities, including annual reports, supplements, and variations.

Cross-Functional Leadership:

• Act as the regulatory subject matter expert on all project teams.
• Review and approve technical documents from our CRO/CMO partners (e.g., validation reports, stability protocols) for regulatory sufficiency.

Qualifications & Experience

Education:

Experience:

• A minimum of 12-15+ years of progressive experience in Regulatory Affairs within the pharmaceutical industry.

• Direct, hands-on experience in successfully filing ANDAs and/or NDAs with the US FDA is mandatory.

• Proven track record of leading interactions and negotiations with the FDA.
• Experience managing the regulatory aspects of a product's full lifecycle.

Skills & Expertise:

• Expert knowledge of US FDA regulations, ICH guidelines, and the eCTD submission process.
• Strong strategic thinking with the ability to balance technical, business, and regulatory considerations.
• Exceptional written and verbal communication skills.
• Demonstrated ability to lead and influence cross-functional teams.
• Experience working with India-based manufacturing partners is a significant advantage.