Associate Director, Regulatory Affairs

This role’s primary responsibility is to partner with Regulatory therapy area leadership in obtaining and maintaining regulatory filings and registrations for domestic and international regions. This Associate Director will coordinate activities with internal team members and external parties (e.g., regulatory bodies; vendors; consultants) to maintain up-to-date information on regulatory requirements and product submissions.

Responsibilities:

• Provide team and department leadership
• Manages most aspects of company regulatory interface with domestic and international health authorities
• Manages the development and deployment of the regulatory program that ensures aggressive product approval
• Manages and may generate regulatory submission documents for new products or changes to existing health authorities' filings, including domestic and international submissions and registration
• Manages and/or oversees project-related nonclinical and clinical submissions
• Maintain up-to-date knowledge of regulatory requirements. Disseminates information regarding governmental regulations and guidances that may affect company processes. Provide expertise in translating regulatory requirements into practicable, workable plans and follows up, as applicable, to assure awareness for company compliance
• Partners with various teams throughout organization (Clinical Operations, R&D, Quality, etc.) on projects
• Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations
• Determines international regulatory requirements and develops plans to comply with national laws in each country
• Provides guidance with localization and labeling requirements
• Manages regulatory reporting requirements for investigational products
• Provide support for meetings with FDA/health authorities
• Help maintain regulatory files
• Support the timely preparation of organized and scientifically valid applications to Health authorities
• Contribute to the development and implementation of standard operating procedures (SOPs) and policies

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong analytical and problem-solving skills.
• Strong written and verbal communication skills, including the ability to interact effectively and to influence.
• Strong attention to detail.
• Customer focused and adaptable, with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations.

Preferred Education and Experience:

• Bachelors or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline.
• Minimum of 5 years of relevant regulatory experience.
  
  

The pay range that the Company reasonably expects to pay for this headquarters-based position is $204,000-$240,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.