Regulatory Affairs Associate Director (US-based role)

Major Duties and Responsibilities

• Develop and lead regulatory strategies and activities across all product life cycles
• Develop strategies to support new product development.
• Manage post-approval regulatory activities and maintain regulatory application while ensuring regulatory compliance.
• Ensure team execution of regulatory activities per the project plan to assure new products meet submission, approval and commercial launch goals. Including management of applications for new marketing authorizations as per FDA requirements and regulations.
• Collaborate with R&D, clinical, and commercial teams on US-specific requirements, and align on the regulatory strategy for global products.
• Lead and negotiate for regulatory affairs in meetings with internal & external stakeholders, working cross functionally to achieve the business goal.
• Provide comprehensive and detailed regulatory advice to support the business including change control SME.
• Identify risks to submissions, propose mitigating strategies, and independently negotiate directly with the FDA to resolve regulatory issues.
• Review and approve documentation prepared by internal and external stakeholders, independently using regulatory knowledge and guidelines to ensure compliance with new marketing applications, including labeling and marketing materials.
• Preparation of new marketing applications according to FDA guidelines and in compliance with eCTD guidelines.
• Evaluate potential pipeline assets and FDA-approved product acquisition targets of strategic interest to the business and conduct regulatory due diligence reviews of assets.
• Review and approve labeling and promotional materials.
• Preparation and review of Regulatory Affairs SOPs.
• Ensure regulatory files and data systems are maintained in compliance with SOPs and KPIs are in line with business goals.
• Support continuous improvements to regulatory and business processes.

 

Competencies

• Strong scientific and U.S. FDA regulatory background
• Thorough understanding of U.S. FDA regulations; understanding of 505(b)(2) applications is crucial
• Awareness of legal framework and litigations around 505(b)(2) applications
• Good understanding of bioequivalence guidelines
• Detailed CMC and eCTD knowledge
• Highly organized and demonstrates good planning and prioritization abilities with flexibility and agility in fast-paced work environment.
• Excellent written and verbal communication skills
• Strong attention to detail

 

Knowledge and Experience

• Typical Years of Experience- Minimum 10 years.
• Minimum Expected Education- Degree in Science discipline, advanced degree preferred