Senior Manager, Regulatory Affairs

Key Responsibilities

• Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence
• Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks
• Manage coordination, preparation, and timely submission of regulatory documents and filings
• Review global regulatory submissions for consistency and quality across regions
• Manage preparation of responses to queries from regulatory authorities
• Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
• Ensure conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments) for assigned programs
• Provide regulatory advice to other functional areas
• Participate in regulatory due diligence activities

Qualifications

• Bachelor’s degree is required, preferably in a scientific field; advanced degree is a plus
• 8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry strongly preferred; experience in cardiometabolic/cardiovascular or endocrinology therapeutic areas is a plus
• Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
• Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissions
• Solid working knowledge of core processes: discovery, development, and manufacturing
• Experience with eCTD requirements and electronic submissions
• Experience with international regulatory submissions and processes is a strong plus
• Able to work effectively across teams, functions and with outside partners
• Excellent oral and written communication skills
• Excellent organizational skills and attention to detail

PAY RANGE

The salary range for this role is $180,000 - $195,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.