Director, Regulatory Affairs

About the role

Leads global regulatory strategies and guides cross-functional teams to assure drug products and devices are developed in line with the applicable regulatory requirements of targeted countries and obtains license approvals (e.g., IND, NDA, ANDA, 510k) and registrations or authorizations for these products to bring safe, approved medicines and devices to market.

Maintains registrations of existing drug products and devices in compliance with applicable regulations.

Prepares and submits post approval reports as required by the US regulations and other regulatory agencies where the product is licensed.

Represents the company in all Regulatory interactions with Health Regulatory Authorities in the US and worldwide, as applicable.

Essential Duties & Responsibilities

• Develops and implements regulatory strategies for development projects and manufacturing improvements and analyzes risk vs. benefit in regulatory strategies to ensure compliance with regulatory requirements and successful review by regulatory authorities.
• Manages team’s preparation of registration packages and responses to deficiency letters to ensure high quality submissions with effective presentation.
• Negotiates and influences submission data requirements and deliverable dates with regulatory authorities as necessary and communicates to internal technical teams.
• Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams.
• Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.
• Identifies new requirements or changing landscape and can lead implementation of these new or updated processes/requirements within the regulatory organization.

Knowledge & Skills

• Interprets global regulations to assure regulatory compliance, minimize product cost and reduce development cycles.
• Strong critical thinking, negotiation, and matrix-leadership skills to guide multidisciplinary teams and influence senior management.
• Develop effective regulatory strategies, as per market plan.
• Negotiates reasonable and attainable regulatory strategies that are innovative, compliant, and sound from a business and technical perspective.
• Follows scientific arguments, identifies regulatory scientific data needs, and solves regulatory issues.
• Performs complex compliance risk/benefit analysis in formulating a recommendation for action.
• Directly influences the development of new products and improvements to existing products, which can increase sales and/or reduce compliance risk.
• Approves regulatory data packages and labeling prior to filing and during the approval process.
• Identifies submission risks and develops mitigation plans to minimize time to regulatory approvals.
• Establish optimal regulatory strategies and successfully negotiates with regulatory agencies when necessary.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age.
• Bachelor’s degree (STEM) from an accredited college or university is required. Advanced degree preferred (PhD, PharmD, MD, or MS).
• Minimum of 10 years’ experience in pharmaceutical drug manufacturing and/or development, with a proven track record in leading major regulatory submissions.
• Minimum of 5 years management experience in regulatory affairs, global regulatory affairs experience is required.
• Experience working directly with regulatory agencies (e.g., FDA, Health Canada).
• Sound knowledge of applicable portions of agency guidance and regulations.
• Excellent communications skills at all levels - both internally and externally.
• Highly proficient in communicating strategic and tactical issues to management.
• Strong interpersonal skills.
• Demonstrated leader.