Wave Life Sciences
Director/Senior Director, Regulatory Affairs
Wave Life Sciences, Lexington, Massachusetts, United States, 02173
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 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
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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 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
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