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Crinetics Pharmaceuticals · 1 day ago

Regulatory Affairs Manager

United States

Full-time

Onsite

Mid, Senior Level

$126K/yr - $158K/yr

5+ years exp

Crinetics Pharmaceuticals is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases. The Manager, Regulatory Affairs will support regulatory strategy implementation and work closely with the Executive Director to prepare regulatory submissions and develop global regulatory strategies.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Actively participate as a member of Regulatory Affairs teams and on cross-functional product development teams as needed

Act as a regulatory lead on a Phase 1, 2 or 3 clinical study

Contribute to developing and implementing regulatory strategies for global submissions from early research and development (R&D) through commercialization

Support the compilation, review and/or filing of INDs, CTAs, briefing documents and maintenance of development and approved applications

Coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, routine submissions, and amendments as needed

Develop and manage project timelines for regulatory submissions

Maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submissions

Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials, and essential document packages

Track submissions, correspondence, and commitments with health authorities

Provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional

Write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate

Conduct regulatory intelligence or research projects as required

Qualification

Regulatory Affairs experienceRegulatory submissions preparationFDA regulationsICH guidelines knowledgeClinical Practice (GCP)MS Office proficiencyProject management skillsMeet deadlinesElectronic document managementCommunication skillsOrganizational skillsInterpersonal skills

Required

Bachelor's or M.S./Ph.D. degree in scientific area

Minimum of 7 years' experience with a Bachelor's or 5 years' experience with M.S./Ph.D. of relevant Regulatory Affairs experience in a biotech/pharmaceutical setting

Minimum of 2 years supervisory experience

Equivalent combination of relevant education and applicable job experience may be considered

Experience and understanding of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) requirements, and FDA regulations

Experience and knowledge in the preparation of regulatory submissions, i.e. US IND and/or NDA sequences

Ability to work both independently with direction and within project teams and see all projects through to their completion

Excellent written and oral communication skills

Strong organizational skills, including the ability to prioritize workload

Strong interpersonal skills and the ability to deal effectively with other people/departments

Ability to meet deadlines and perform multiple tasks in a fast-paced setting

Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: Advanced MS Word and Adobe PDF knowledge required