The Manager/ Sr. Manager, Regulatory Affairs will manage, evaluate, and complete regulatory projects consistent with company goals. The Sr. Manager, Regulatory Affairs will be responsible for tracking regulatory commitments, deliverables and submission content in each region. Responsibilities will span all clinical trials from early stage through NDA/BLA. The Sr. Manager, Regulatory Affairs will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. Working closely with departmental leadership, the Sr. Manager, Regulatory Affairs will represent Regulatory Affairs on cross-functional project teams, will provide departmentally aligned input to the project team, will lead authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive.
Essential Duties and Responsibilities
- Assist in the development and implementation of a global regulatory strategy for assigned projects, along with Global Regulatory Lead(s) and Regulatory CMC.
- Collaborate with Regulatory Operations to compile and review regulatory submissions for completeness and quality.
- Ensure that submissions are in conformance with the latest industry and health authority submission standards
- Assist with logging, tracking and filing of correspondence and submissions to/from regulatory authorities and ensure that no commitment remains outstanding.
- Identify and draft necessary SOPs and/or Working Practices for Regulatory Affairs.
- Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions.
- Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances, and current industry practice.
- Manager Level requires Bachelor’s degree in scientific discipline with 7 years pharmaceutical industry experience, including 5+ years in Regulatory Affairs. Sr Manager level requires Bachelor’s degree in scientific discipline with 9 years pharmaceutical industry experience, including 7+ years in Regulatory Affairs.
- Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical). Experience with CTD/eCTD.
- Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle.
- Working knowledge of FDA and ICH regulatory guidance and regulations.
- Experience of Regulatory Intelligence Management (RIM) or Electronic Document Management System (EDMS) would be an advantage.
- Strong organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Self-motivated, takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
- Knowledgeable in industry trends for regulatory affairs.
- Clinical Study support experience required.
- Domestic and occasional International travel may be necessary.
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
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This position does NOT provide sponsorship so please do NOT apply if you require sponsorship. Thank You
KP Recruiting Group
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