Senior Manager, Regulatory Affairs CMC
- Compensation
- Not disclosed
- Location
- Radnor, Pennsylvania
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 2+ years
- Category
- Legal
- Posted
Skills
Must have
- 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 Regu
- Bachelor’s degree or equivalent in a related discipline. Science or pharmacist major is 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. and EU regulations and expectations for pharmaceutical products, standards for quality, data requirements and knowledge of the regulatory review and approval process
- 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
- 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 ass
- 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.
Full description
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
We are seeking a Regulatory Affairs – CMC professional to join our team as Senior Manager, Regulatory Affairs – CMC, reporting to the Director, Regulatory Affairs – CMC. You will collaborate with Regulatory Affairs, Technical Operations (drug substance, drug product, and analytical/QC subject matter experts), Supply Chain, and/or Quality Assurance to execute on regulatory submission plans based on an existing strategy, as well as identifying and implementing refinements to better support the execution process.
Regulatory submissions may include Original Marketing Applications, post-approval supplements, INDs, Q-IMPDs, amendments, briefing packages, and responses to queries. You will serve as a technical regulatory-focused resource for colleagues, mainly supporting commercial/post-approval activities.
Your responsibilities include:
- 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.).
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 is preferred. An advanced degree in a related discipline is preferred.