What You’ll Do:

The Associate Director, Global Regulatory Affairs will be responsible for day-to-day regulatory activities of early/late phase investigational products, leading the writing and submission of IND/CTA/amendments and future marketing application submissions, providing guidance to the team on regulatory filings and responses, and providing critical regulatory intelligence and guidance back to the team. The Associate Director will work on cross-functional teams, partnering with key internal/external team members including Regulatory CMC and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Serve as the regulatory representative on core teams, developing and planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities
• Oversee the compilation, review, and submission of regulatory applications and submissions to agencies, ensuring accuracy, completeness, and timeliness
• Monitor the regulatory environment and communicate developments to various stakeholders within the company (clinical, regulatory, senior leadership, etc)
• Stay updated on global regulatory guidance and regulations, communicating key updates to senior leadership and project team management to ensure compliance with all reporting requirements, including annual and periodic reports
• Respond to regulatory questions from various regulatory authorities, working in collaboration with subject matter experts in clinical development, safety, and other business partners
• Provide strategic regulatory guidance for global development and registration programs (e.g., INDs, CTAs, NDAs, and MAAs)
• Assess and communicate regulatory requirements to ensure all development activities follow applicable regulations and guidelines
• Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs

Required Qualifications:

• Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
• Established working knowledge of regulatory guidelines and regulations (US and international)
• Demonstrated deep knowledge of the integrated drug development process
• Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
• Demonstrated ability to assess and manage risk in a highly regulated environment
• Strong written, spoken, and presentation communication
• Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities
• Travel expected (10-15%)

Preferred Qualifications:

• Advanced degree preferred

Education:

• Bachelors degree with 10+ years of relevant drug development experience
• Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience