Top Regulatory Affairs Executive jobs in Boston, MA

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:

Reporting to the Sr. Director of Regulatory Affairs and Policy, this role will support and lead activities within the Regulatory group to advance development of the assets in Wave’s pipeline to registration and launch; will collaborate closely with team members within the group and across drug development disciplines such as CMC, Nonclinical, Clinical and Quality.

Experience:

• BA/BS degree in life sciences, MS preferred
• At least 6-8 years of pharmaceutical product development 

Responsibilities:    

• Deliver on the strategic direction for the assigned development programs; provide guidance to and collaborate with the relevant subject matter experts to ensure timely execution of regulatory milestones. 
• Promptly identify and communicate regulatory risk areas and develop mitigation and/or contingency plans; asses the need for revision of the regulatory strategy or tactics 
• Lead and support preparation of high-quality global regulatory submissions compliant with applicable requirements to meet the corporate goals 
• Ensure consistency, completeness and adherence to standards for all regulatory submissions
• Monitor and analyze the continuously evolving regulatory environment to identify changes in regulations and guidelines, new initiatives, etc. Assess their impact and communicate to program teams.
• Participate in the development and review of standard operating procedures to ensure compliance with current regulatory requirements
• Assist with regulatory agency inspections; monitor external consultants

Key Skills:

• Well-versed in regulatory strategy, and regulatory writing
• Experience as primary regulatory author for IND and CTA documents; experience with EU CTR would be beneficial.
• Knowledgeable in ICH, FDA and EMA guidelines
• Knowledge of eCTD structure
• Critical thinking and problem-solving 
• Ability to work independently and thrive in a fast-paced environment
• Attention to detail
• Excellent communication 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.