Manager, Regulatory Strategy 6/5/2020
JOB DESCRIPTIONAPPLY The Global Regulatory Affairs Manager supports multiple products registration and clinical trial activities. This role is expected to serve as the regulatory affairs lead for clinical trial activities, including but not limited to CTA filings, response to agency queries, IP release, label review, etc. The Global Regulatory Affairs Manager also manages routine submissions and assists the Global Regulatory Lead with other operational activities as needed.
PRIMARY RESPONSIBILITIES INCLUDE:
* Serve as the regulatory lead for phase 1-3 clinical studies; participate in clinical trial teams and manage activities of regulatory vendors in preparation of high-quality submission packages
* Provide US regulatory input and ensure regional alignment with global regulatory strategies
* Work with cross-functional teams to produce routine and complex submissions by developing content, creating timelines, driving team review and completion of submissions for CTAs, IMPDs, IB. Track submission and approval status
* Manage submissions of study reports, IND and NDA annual reports, Orphan drug annual reports
* Assist regional and global regulatory leads in developing complex submissions, such as orphan drug designation requests, pediatric investigational plans, and response to agency questions
* Support GRL in managing meetings, roundtable discussions (agenda and notes), and timelines
* Participate in the global regulatory teams (GRTs). Assist the GRL in managing GRT deliverables
* Conduct regulatory intelligence search to ensure regulatory strategies reflect up-to-date regulatory trends
* Perform other duties as required
EDUCATION AND SKILLS REQUIREMENTS:
* BA/BS degree or an advanced degree in a science related field with 5-7 years of experience working in a Regulatory environment
* Knowledge of drug development and regulatory process. Knowledge of ICH guidelines, IND/ CTA, IMPDs, Orphan drug designation
* Experience working in regulatory teams
* Detailed knowledge of clinical and nonclinical data requirements for product labeling
* Demonstrated experience and a clear understanding of submission content and format requirements
* The ability to multitask, prioritize, and work under pressure in adhering to deadlines
* Excellent interpersonal, collaboration, written, verbal communication skills
* Proven ability to successfully manage projects and timelines, organize/track complex information, and prioritize accordingly
* Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details
* Experience working with stakeholders/partners
* Proficiency with Microsoft Office Applications; Word, Excel, Outlook and Adobe Suite systems
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.