Director, Regulatory Affairs

The Role:

The Director of Regulatory Affairs will be responsible for leading the development and implementation of a consolidated regulatory strategy (including regulatory operations) to secure and maintain market access for the assigned product through all development phases. The Director is also responsible for establishing and maintaining effective relationships with regulatory agencies, especially the FDA. This person will lead a team of regulatory professionals. and advise employees on regulatory requirements for all dosage forms and delivery systems and recommend appropriate actions.

Key Responsibilities:

• Develop and implement the global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC.
• Represent and communicate on all regulatory issues involving the FDA and other regulatory health authorities for all products and businesses.
• Lead global and/or regional regulatory teams on assigned projects.
• Provides Leadership to the Regulatory department. Responsible for training, development of the current regulatory team, and selection and hiring of new team members.
• Develop and execute US regulatory strategy and contingencies for assigned projects.
• Serve as the primary interface for FDA on assigned projects.
• Responsible for the review and approval of Standard Operating Procedures (SOP) relating to the preparation, submission, and reporting of information to regulatory authorities. Prepare, plan, and implement new processes and policies to improve the efficiency of the Company.
• Communicate project regulatory strategies and plans to management, cross-functional teams, and any partners/collaborators to establish alignment.
• Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks.
• Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, Marketing Applications, etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned.
• Prepare company team for FDA and other health agency meetings, as required.
• Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions.
• Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and guidance.

Desired Experience/Education and Personal Attributes:

• Bachelor’s degree in a scientific discipline; advanced scientific degree preferred.
• Regulatory Affairs Certification is highly desirable.
• 10+ years of pharmaceutical industry experience, including 7+ years in Regulatory Affairs leadership roles; Global experience desired.
• Experience in multiple phases of development in various therapeutic areas.
• Demonstrated experience in preparing FDA submissions.
• Knowledge of the drug development process and global submission process.
• Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy.
• Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
• Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
• Must be able to innovate, analyze, and solve problems with minimal supervision and attention to detail.