What You’ll Do:

Reporting to the Vice President, CMC Regulatory, the Director of Regulatory Affairs, CMC will support the development and execution of global regulatory CMC strategies. This individual will ensure that regulatory strategies are effectively implemented and maintained in line with changing regulatory and business needs. They will support the day-to-day regulatory activities of assigned products, identify and gather data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed to meet relevant global regulatory requirements. Additionally, they will manage regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

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

Responsibilities:

• Responsible for one or more product(s) and supports the regulatory CMC team in the development & execution of global regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
• Plan and execute regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities
• Define CMC content (data and documentation) requirements for regulatory submissions and conformance with established requirements
• Leads CMC preparation activities for meetings with Health Authorities on CMC related matters
• Ensure timely preparation of CMC documents and responsible for handing off submission ready documents for regulatory submissions
• Contribute to the evaluation of change proposals for global regulatory impact and support planned global variations and amendments
• Identify and communicate critical topics and risk promptly to the regulatory CMC team
• Oversee the copyediting, finalization, approval, and hand-off of documents for publishing

Required Qualifications:

• 10+ years regulatory CMC experience, including experience as a regulatory CMC product lead, or equivalent industry experience

• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
• Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams
• Able to work independently and complete projects with minimal oversight, escalating issues to regulatory management with discretion
• Self-starter and results-oriented individual with outstanding work ethic; must be able to perform in a fast-paced environment
• Demonstrates leadership, problem-solving ability, attention to detail, flexibility, and values teamwork
• Exercises good judgement in elevating and communicating actual or potential issues to line management
• Ability to multi-task and adjust priorities quickly while working under tight deadlines
• Experience using electronic document management systems and document review tools

• Domestic or international travel may be required (eg, to attend health authority meetings)

Preferred Qualifications:

• Experience with peptides is preferred

 

Education:

• BS/BA Degree in a scientific discipline
• Advance degree in a scientific discipline (preferred)