Senior Manager, Regulatory Affairs CMC

Cytokinetics, Inc.; Radnor (Delaware County); Hybrid; USD 177,000 - 207,000; Full time

Benefits offered by this job

Health, Dental, Vision, Life Insurance

Disability insurance

401(k) with employer match

Stock options / RSUs

Learning & wellness stipends

Paid time off

Job summary

Cytokinetics, Inc. is seeking a Senior Manager, Regulatory Affairs – CMC to drive CMC regulatory filings and strategy in a hybrid role based in Radnor, PA.

You will coordinate cross-functional teams across Regulatory Affairs, Quality Assurance, Technical Operations and Global Supply Chain to ensure timely, accurate submissions for US and EU markets. Ideal candidates have 5+ years in pharma/biotech regulatory affairs with CMC focus, strong knowledge of GDP/GMP, and experience with VEEVA RIM/EDMS

Qualifications

• 5+ years as Regulatory professional in pharma/biotech (CMC focus)
• 2–3 years in Regulatory Affairs-CMC
• Bachelor’s degree; science/pharmacist preferred; advanced degree preferred
• Familiarity with global regulatory guidelines for CMC development and commercialization
• Understanding of US/EU regulatory expectations, GDP/GMP
• Experience generating technical registration dossiers for US/EU
• Knowledge of submission processes and systems (Module 2.3/3, VEEVA)
• Strong written and verbal communication; ability to influence and resolve conflicts

Responsibilities

• Lead/co-ordinate execution of CMC regulatory filing strategy
• Manage regulatory processes to achieve timely submission
• Prepare high-quality CMC regulatory documents per company standards
• Collaborate with RA, QA, and Technical Operations across the value chain
• Monitor regulatory changes to inform strategy and stage-specific requirements
• Support or lead regulatory-related QA processes and system changes

Skills

Regulatory strategy

Cross-functional collaboration

Documentation & dossiers

Regulatory interpretation

GDP/GMP knowledge

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

VEEVA – RIM/EDMS

eCTD submissions

Job 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. 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 and analytical methods). 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. Ability to influence, facilitate issue resolution, and manage conflicts is a plus.

#LI-HYBRID Pay Range: The expected salary range for this position based on the primary location of Radnor, PA is $177,300-$206,850. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. 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.

Cytokinetics is an Equal Opportunity Employer.