Senior Manager, Regulatory Affairs CMC

We are seeking a Regulatory Affairs - CMC professional to join our team as Senior Manager, Regulatory Affairs – CMC. In this role, you will collaborate with Regulatory Affairs, Technical Operations (CMC, Analytical), Supply Chain, and/or Quality Assurance to lead, coordinate and/or prepare drug substance and drug product document packages for regulatory submissions (e.g., IND, CTA/IMPD, amendments, briefing packages, responses to queries), working independently within guidelines and policies. You will serve as a regulatory-focused resource for colleagues, supporting pre-IND/IND through late stage programs as we transition from development to commercial environment.  

Your responsibilities may include:

• leading/coordinating execution of (CMC) regulatory filing strategy, and managing or supporting regulatory processes to achieve timely approval
• preparing high quality CMC regulatory documents or packages in accordance with company standards and procedures, ensuring thoroughness, accuracy, and timeliness
• building strong collaboration with internal stakeholders, including Regulatory Affairs, Quality Assurance, Technical Operations and Global Supply Chain; providing functional expertise to matrix/cross-functional teams
• maintaining current knowledge of regulatory intelligence and processes that may impact regulatory-CMC planning; and keeping abreast of changes in the regulatory environment to better inform stage-specific CMC requirements for clinical studies
• collaborating with regional affiliates and/or colleagues to ensure that local regulatory authority requirements are met
• providing regulatory support for relevant quality systems such as change control, or discrepancy management
• communicating status and potential risks to defined regulatory strategies, timelines, or approvability
• assisting preparation of teams or materials to support regulatory authority interactions or internal communications at the team or governance level
• supporting or leading non-program-specific projects as assigned (e.g., department initiatives, training, due diligence, etc.).

Qualifications

• Regulatory professional with 5 years of industry experience in pharmaceutical, biotechnology or related industry in CMC, Regulatory, Quality, R&D, and Manufacturing or related, with 2-3 years in Regulatory Affairs-CMC

• Bachelor’s degree or equivalent in a related discipline. Science or pharmacist major preferred. An advanced degree in a related discipline is preferred.
• Familiarity with global regulatory guidelines and requirements specific to the CMC development and commercialization of small molecules. Ability to interpret global regulations and guidance
• Understanding of the U.S. drug laws, FDA regulations and expectations for pharmaceutical products, FDA standards for quality, data requirements and knowledge of the NDA review process
• Experience with generating technical registration dossier for the US and EU is preferred
• Experience with small molecule drug development, late stage drug development, and commercial stage programs is a plus. (knowledge of pharmaceutical development, including drug substance, drug product and analytical methods)
• Ability to create/maintain regulatory submission content plan, timeline, submission strategy, and establish submission structure in electronic common technical document format for Module 3
• Understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
• Outstanding interpersonal and communication (written and verbal) skills
• Ability to influence, facilitate issue resolution, and manage conflicts is a plus.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer