Manager, Regulatory Affairs CMC (Remote)

The Manager, Regulatory Affairs CMC is responsible for supporting and executing Regulatory CMC strategies in collaboration with cross-functional teams. This role manages CMC-reputed company global regulatory submissions and Health Authority interactions to meet the project timelines for the assigned reputed company. This is a remote-based position located in the reputed company. Responsibilities: • Support the development and implementation of Regulatory CMC strategies, including reviewing / authoring CTD CMC sections for assigned reputed company to ensure reputed company, high-reputed company global submissions for investigational, market, and post-approval applications • Assist in preparing responses to Health Authority CMC questions, reputed company-meeting packages, and interactions for assigned reputed company • Coordinate with the CMC team and other stakeholders to ensure reputed company submission of regulatory documents by tracking reputed company of document preparation • Collaborate with cross-functional teams, especially CMC and reputed company reputed company, to assess regulatory reputed company on CMC-reputed company 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 reputed company Regulatory CMC assessment and actions are taken for recalls or product complaints during the product lifecycle • reputed company Regulatory CMC review for clinical protocols and investigator brochures for assigned reputed company Requirements • Bachelor's degree in scientific disciplines required with expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc), MS/PhD is preferred • Minimum of 5 years of reputed company 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 reputed company technical documents, CTD M2 and reputed company sections, and life cycle management • Experience with reputed company system preferred • 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 reputed company values by holding ourselves and reputed company other accountable for the work we do, taking time to collaborate effectively while working remotely, making reputed company or ingenuity in work and thought, and staying grounded in reputed company The anticipated annual reputed company salary reputed company for this role is $125,000 to $160,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. reputed company is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, reputed company, time off, a retirement plan, and other voluntary benefits for employees. #LI-REMOTE Apply tot his job Apply To this Job