Senior Director, Regulatory Affairs

Wave Life Sciences • Lexington, MA

4h • $248,000 - $335,000

About The Position

The
Senior Director, Regulatory Affairs is responsible for developing and
executing the global regulatory strategy for assigned programs. Reporting to
the Vice President, Regulatory Affairs and Policy, this
individual represents Regulatory Affairs in the setting of cross-functional
program teams and provides risk-based strategic and tactical guidance to meet
the corporate goals. This position will develop and advance organizational
policies and procedures, while also monitoring changes in the regulatory
environment that may impact current or future program objectives.

Requirements

• BA/BS degree in life sciences, M.Sc. or Ph.D. as a plus
• At least 15+ years in the pharmaceutical industry, with a minimum of 6 years in regulatory affairs
• Well-versed in regulatory strategy, and regulatory writing
• Experience as primary regulatory author for of IND and CTA documents
• Experience in communicating regulatory strategy, submission documents and plans both internally and externally
• Knowledgeable in ICH, FDA and EMA guidelines, and familiarity with GCP,GLP, GRP
• Extensive experience in working with regulatory health authorities such as FDA,EMA, Health Canada across all phases of clinical development; orphan drug experience is a plus
• Sound understanding of the scientific principles underlying the regulatory requirements
• Strong knowledge of eCTD elements and structure and regulatory writing skills
• Ability to work independently and thrive in a fast-paced environment
• Attention to detail
• Team player with the ability to be a situational leader when required
• Strong analytical and strategic thinking skills
• Project and submission management skills

Responsibilities

• Lead the timely preparation, review, publishing and submission of documents to regulatory authorities, and maintain compliance with applicable regulatory requirements and best industry practices
• Provide strategic guidance and insightful interpretation of applicable global/regional regulations in support of regulatory milestones such as IND, CTA, NDA, MAA; regulatory agency interactions; etc
• For the products assigned, lead and/or co-author the preparation of information packages for regulatory submissions; review these packages for conformance with established regulatory requirements and company standards
• Assess opportunities for expedited pathways, such as US Breakthrough Therapy Designation or Priority Medicines
• Effectively communicate with internal and external team members, senior leaders and key stakeholders on the status of, risks and mitigation plans associated with the regulatory milestones
• Coordinate with the appropriate in-house stakeholders the preparation of responses to queries from regulatory authorities and ensure timely submission
• Ensure regulatory commitments are addressed diligently, within the required timeframe
• Support continuous improvement of existing department processes and strategies
• Keep abreast of regulatory guidance and technical/scientific developments relevant to projects. Contribute to commenting on draft regulations and assess future areas for influencing the regulatory environment

Benefits

• company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), and 401K participation with matching contributions

What This Job Offers

• Job Type: Full-time
• Career Level: Director