Senior Director, Regulatory Affairs

POSITION SUMMARY

The Senior Director, Global Regulatory Affairs will play a significant role in providing regulatory strategic leadership on multiple clinical development programs associated with rare diseases in assigned Therapeutic Area (TA). This role will represent the regulatory function and provide guidance to Program Teams across the organization which include Clinical Development, Clinical Operations, Biometrics, Nonclinical Science, Drug Safety and Pharmacovigilance, and Quality Assurance for assigned projects. This role will be the Global Regulatory TA Lead, responsible for ensuring global regulatory compliance and overseeing timely delivery of submissions and approvals of regulatory procedures including but not limited to IND, NDA, MAA, and life cycle management activities for multiple projects.

JOB FUNCTIONS/RESPONSIBILITIES

• Develops and oversees the global regulatory strategy for projects in assigned TA, in conjunction with and under the leadership of the SVP, Global Regulatory Affairs.
• Leads the Global Regulatory Project Team meetings in collaboration with Regulatory Project Management when being the Global Regulatory Lead on a project.
• Oversees the preparation of regulatory documentation (meeting request/briefing books) in support of interactions with a Health Authority and provide guidance to their team.
• Oversees/leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements.
• Contributes to and reviews responses to global Health Authority questions to ensure appropriate, consistent, and complete responses, ensuring their alignment with global development strategy.
• Provide global regulatory advice through the product life cycle by representing the regulatory function in the Program Team when being the Global Regulatory Lead on a project.
• In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations/amendments internationally in assigned TA.
• Actively participates in Health Authority meetings.
• Clearly articulate regulatory challenges/risks, identify potential solutions, and make a recommendation(s) on a path forward to Program Teams and Senior Management.
• Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating regulatory changes to Program Teams.
• Effectively manages direct report(s) and provide mentorship to junior professionals.

QUALIFICATIONS

Education /Experience:

• Bachelor’s or Master’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); an advanced degree is desirable.
• A minimum of 15 years in the pharmaceutical industry with a minimum of 12 years in Global Regulatory Affairs, experience with major Health Authorities (US FDA, Health Canada, and EMA) is mandatory.
• Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred.
• Experience in all phases of development and post marketing activities is highly preferred.
• Demonstrated ability to analyze and interpret efficacy and safety data.
• Strong understanding of regulatory operational activities.
• Outstanding people management skills are required.
• Outstanding interpersonal and communication skills.
• Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on the regulatory strategy for a given product is required.
• Demonstrated proficiency in organizational awareness, including experience working cross-functionally representing the Regulatory Affairs function and on global teams.
• Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines.
• Supports the SVP, Global Regulatory Affairs as required.

Work Environment:

• This is a high-growth, fast-paced organization. The ability to be productive and a team player is critical.
• Ability to work under minimal supervision.
• Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10-15% of work time.
• On site presence at the headquarters is required (minimum 2 days a week).

The salary range for this position is $280,000 to $310,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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