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Elevar Therapeutics · 18 hours ago

Manager, Regulatory Affairs CMC (Remote)

United States

Full-time

Remote

Mid, Senior Level

$125K/yr - $160K/yr

5+ years exp

Elevar Therapeutics is a rapidly growing biotech company, and they are seeking a Manager, Regulatory Affairs CMC to support and execute Regulatory CMC strategies. This role involves managing global regulatory submissions and interactions with Health Authorities to meet project timelines.

BiotechnologyHealth CareMedicalPharmaceuticalProduct DesignTherapeutics

Responsibilities

Support the development and implementation of Regulatory CMC strategies, including reviewing / authoring CTD CMC sections for assigned projects to ensure timely, high-quality global submissions for investigational, market, and post-approval applications

Assist in preparing responses to Health Authority CMC questions, pre-meeting packages, and interactions for assigned projects

Coordinate with the CMC team and other stakeholders to ensure timely submission of regulatory documents by tracking progress of document preparation

Collaborate with cross-functional teams, especially CMC and Quality groups, to assess regulatory impact on CMC-related issues

Contribute to regulatory risk assessment, identify key Regulatory CMC issues, and support mitigation activities throughout the product lifecycle

Participate in developing internal Regulatory CMC guidance and working instructions

Ensure proper Regulatory CMC assessment and actions are taken for recalls or product complaints during the product lifecycle

Provide Regulatory CMC review for clinical protocols and investigator brochures for assigned projects

Qualification

Regulatory CMC experienceCMC module preparationICH requirements expertiseVeeva systemProject management skillsCommunication skillsAttention to detailCollaboration skills

Required

Bachelor's degree in scientific disciplines required with expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc)

Minimum of 5 years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience

Experience in leading the preparation of CMC modules to support CTA, NDA/MAA submissions, and subsequent responses to HA queries

Expertise of ICH requirements and US/EU regulatory requirements

Experience with regulatory CMC requirements for EU markets and GMP regulation

Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management

Excellent oral and written communications skills with attention to detail

Strong project management skills, including coordinating teams and managing timelines for regulatory submissions

Ability to demonstrate Elevar's core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space or ingenuity in work and thought, and staying grounded in compassion