The Senior Director Regulatory Affairs will be responsible for developing and implementing global regulatory strategies on Class III device, drugs and drug-device combination products. Ensures timely preparation of organized and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-related topics. Requires ability to work strategically, both independently and in a team environment.

QUALIFICATION REQUIREMENTS:

Education:

• Bachelor’s degree in a Scientific discipline. Advanced degree preferred.

Experience:

• 10+ years regulatory experience, ideally with drug device combination products and/or device submissions experience.
• Prior experience representing Regulatory Affairs on cross-functional teams is a plus
• Proven capability to effectively lead teams in preparation of submissions.
• Must have extensive knowledge of regulatory requirements, including ICH, US FDA and regional requirements. Must have an understanding of current global and regional trends in regulatory affairs with the ability to assess the impact of these requirements to the business.
• Must be capable of critically reviewing complex technical documents and influencing colleagues across functions.
• Experience with drug-device combination products preferred.

Knowledge/Skill:

• Excellent leadership, organizational and project management skills.
• Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed.
• Work both independently and by supporting the regulatory team.
• Must have outstanding communication and collaboration skills within cross-functional teams and external organizations.
• Ability to work in a fast-paced virtual environment.
• Excellent verbal and writing skills.
• Excellent editing and proof-reading skills.
• Possess a self-directing, self-starting work ethic.

PRINCIPAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING:

The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.

• Responsible for strategic and operational regulatory input for cross functional (non-clinical and clinical) areas in collaboration with other project team members and regulatory colleagues.
• Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure compliance and product expansion.
• Acts as the company representative with regulatory authorities.
• Prepares and/or manages submissions that are technically complex and may require extensive interaction with departments outside of regulatory affairs.
• Contributes to internal regulatory policies and procedures to achieve best practices and work processes.
• Work both independently and by supporting the regulatory project team.

SUPERVISORY RESPONSIBILITIES:

• Direct reports: to be defined as the team grows
• Indirect reports: external consultants