Our biotechnology client has an immediate need for a Sr. Manager, Regulatory Science on a full-time basis in their Los Angeles location. You will primarily support the US regulatory aspects of regulatory affairs for their lead product, research & summarize regulatory intelligence, provide regulatory input for regulatory submissions and work closely with colleagues to compile & review submissions for completeness and quality.
This position may manage employees of the department and is responsible for the performance management and hiring of any employees reporting to this role within that department.
- FDA contact for assigned projects.
- Participates in global regulatory team, study teams, and ad hoc meetings as a regulatory affairs representative.
- Offer submission strategies and identifies potential regulatory risks.
- Tactical support for the timely preparation, editing and review of submissions, including Health Authority Meeting Requests & Briefing Documents, IND/CTA amendments, NDAs/NDSs/MAAs and their respective amendments/supplements
- Support creation of cover letters, forms, and other required documentation for applicable submissions including drafting of proposed US labels.
- Liaises internally and externally on applicable submission documents including the uploading and routing of documents in EDMS and the review of documents.
- Assist in the global strategy for potential new markets and regulatory intelligence for indications of interest.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Provide interpretation of new regulations, guidance documents and directives; and advises on impact on internal programs.
- Compile and maintain global regulatory documentation databases or systems.
- Archive global submissions and regulatory correspondence.
- Complete CTA Questionnaires for all studies on monthly basis.
- Build and maintain spreadsheets that will calculate and organize business metrics as required.
- Compose or update standard operating procedures, work instructions, or policies as needed.
- Support Global MAA with Regional Partners
- Manage ex-US CTAs through local regulatory consultants
- Excellent listening and communication skills, with an ability to accept direction and feedback
- Minimum of Bachelor’s degree
- Degree(s) should be in Life Sciences/Health Related Sciences from an accredited college or university
- Had prior US Regulatory Lead, FDA contact, or directly related experience, preferably in the oncology therapeutic area