Associate Director, Regulatory Affairs

POSITION SUMMARY

The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory activities for the dedicated regions and related to the development and commercialization of novel liver drugs including quality, preclinical and clinical areas of drug development. This position will manage the timely delivery of regulatory applications by working with internal stakeholders and with corporate partners and distributors across multiple countries as assigned. The role is responsible for ensuring full regional regulatory compliance, and overseeing submissions and approvals of regulatory procedures including but not limited to IND, NDA, MAA, , and life cycle management activities.

JOB FUNCTIONS/RESPONSIBILITIES

• Leads the Regulatory strategy for the assigned projects under the supervision of the Global Regulatory Lead.
• Leads the Global Regulatory Team Meetings when required by the Global Regulatory Lead.
• Leads the preparation of regulatory documentation in support of Regulatory Authority Interactions (briefing books).
• Support the Clinical Operation Team with Clinical Trial Applications.
• 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 answers to health authority questions; ensures responses are aligned with global development strategy.
• Establishes and maintains excellent relationships with international partners and distributors and will be the primary point of contact for partners and distributors as assigned.
• Provide global regulatory support through the product life cycle by participating in the global project teams (e.g., collaboratively develop international regulatory strategies, timeline development, change control and preparing submission related documents).
• In collaboration with Regulatory project managers, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations and amendments internationally.
• Actively participates in health authority meetings, when required.
• Supports the Global Regulatory Lead as required.

QUALIFICATIONS

• 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 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs, experience with major Health Authority (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 health authority negotiations.
• Experience with regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), post marketing measures, Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities).
• Experience in all phases of clinical development is preferred.
• Demonstrated ability to analyze and interpret efficacy and safety data.
• Strong understanding of regulatory operational activities.
• Outstanding management, interpersonal, communication, negotiation, and problem-solving skills.
• Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global teams.

Work Environment:

• This is a high-growth, fast-paced small organization. The ability to be productive and successful in a work environment is critical.
• 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 Headquarter is required (minimum 2 days a week).

#LI-Onsite

#J-18808-Ljbffr