Senior Manager, Regulatory Affairs CMC

Cytokinetics•Radnor, PA

1d•Hybrid

About The Position

Cytokinetics is a specialty cardiovascular biopharmaceutical company focused on developing medicines for cardiac muscle diseases. They are seeking a Regulatory Affairs – CMC professional to join their team as Senior Manager, Regulatory Affairs – CMC. This role involves collaborating with various departments to execute regulatory submission plans, identify process improvements, and serve as a technical regulatory resource, primarily supporting commercial/post-approval activities. The position requires leading and coordinating CMC regulatory filing strategies, preparing high-quality regulatory documents, and maintaining knowledge of regulatory intelligence.

Requirements

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.
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. and EU regulations and expectations for pharmaceutical products, standards for quality, data requirements and knowledge of the regulatory review and approval process
Strong familiarity with typical regulatory submission processes and systems (e.g., submission content plans, timelines, eCTD submissions (Module 2.3 and 3), VEEVA – RIM/EDMS, change control impact assessments)
Understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
Outstanding interpersonal and communication (written and verbal) skills

Nice To Haves

Science or pharmacist major is preferred.
An advanced degree in a related discipline is preferred.
Experience with generating a 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 influence, facilitate issue resolution, and manage conflicts is a plus.

Responsibilities

Leading/coordinating execution of (CMC) regulatory filing strategy, and managing or supporting regulatory processes to achieve timely submission
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; proactively monitoring changes in the regulatory environment to better inform stage-specific CMC requirements for clinical development programs
Providing regulatory support for relevant Quality and Regulatory processes and systems such as change controls and VEEVA - RIM
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.)