Job Description

Reporting to the Head of Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading CMC regulatory activities that support the company’s product development strategies and providing guidance to broader CMC functions.

This individual will ensure all applicable global CMC regulatory requirements are considered and appropriately incorporated into clinical and commercial product development plans. This individual will work collaboratively with senior leadership and key stakeholders to develop global CMC regulatory objectives for one or more programs, lead the preparation and filing of global regulatory CMC submissions and manage the preparation for interactions with Health Authorities.

The Director will be effective in collaborating within the organization and provide leadership by communicating, executing, and providing guidance to team members toward achieving the department/corporate objectives.

Essential Functions:

• Lead the development of CMC regulatory strategy for assigned programs, identifying key issues, necessary remediation activities, and opportunities for acceleration throughout project/product life cycle
• Serve as the regulatory representative at internal CMC team meetings, core submission meetings and other cross functions meetings.
• Provide global regulatory Affairs-CMC strategic guidance to project teams and ensure timely development and execution of project plans.
• Assess and communicate CMC regulatory requirements to ensure all global development activities comply with applicable regulations and guidelines in each jurisdiction
• Initiate and lead discussions with health authorities to proactively obtain scientific advice/agreement and resolve CMC issues in a timely manner.
• Facilitate the preparation for CMC-focused meetings with FDA, EMA, PMDA or national competent authorities, and participate in or lead the interactions with these agencies
• Support Quality and tech ops during GMP inspections
• Work within a cross-functional team to coordinate and prepare high quality, timely correspondence and global CMC regulatory submissions (e.g., original INDs, CMC amendments, IMPD Amendment, annual reports, Agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development
• Work directly with external contractors and collaborators, managing the chain of communication and updating regulatory project plans as necessary for accuracy and success
• Provide input on project related budgets and ensure projects operate within capital and expense budget guidelines
• Coordinate and conduct global CMC regulatory project review sessions, determine frequency and content of status reports, and deliver routine updates including presentations to Regulatory department, Product Development Team Lead, or executive management, as required
• Keep appraised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities
• Coordinate with appropriate team members and stakeholders to resolve outstanding CMC regulatory issues

Requirements / Qualifications:

• Bachelor’s degree in a field of science such as Biology, Chemistry, or Pharmaceutical Sciences. Advanced degree preferred but not required.
• A minimum of 10 years of increasing responsibility in CMC Regulatory Affairs within the biopharmaceutical industry is required.
• Prior experience in successful submission and approval of market applications is required.
• Candidates must have global post-approval experience for life-cycle management of products
• Candidates must have proven strategic development capabilities related to new drug development and commercial support activities.
• Demonstrated recent successful global Regulatory Affairs track record in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the US, EU and internationally.
• Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies
• Demonstrate excellent teamwork and communication skills with the ability to impact and influence the decisions of a team.
• Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
• Strong oral and written communication, time management, and team-oriented leadership skills are essential
• Excellent computer and project management skills are essential for the successful candidate.
• Ability to work in a fast paced-environment and to handle multiple tasks.

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