Senior Director, Regulatory Affairs

Job Description

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description

The Director/Senior Director, Regulatory Affairs is responsible for developing and executing the global regulatory strategy for the programs assigned. Reporting to the Head of 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.

Experience

• BA/BS degree in life sciences, M.Sc. or Ph.D. as a plus
• At least 12 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
  
  

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
  
  

Key Skills

• 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
  
  

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.