Senior Director, Regulatory Affairs CMC Europe

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.

Reporting to the Executive Director, Regulatory Affairs - CMC, the Senior Director, Regulatory Affairs-CMC will serve as a spokesperson for Regulatory Affairs-CMC on programs or topics of major import. He/she will have full responsibility (planning and strategic implementation) for multiple programs or broad areas of significant cross-functional impact, with a 1 – 3 year planning horizon. Activities may include:

• Accountability for global CMC regulatory submission strategies for initial marketing applications and post-approval life-cycle management
• Effective cross-functional collaboration with project teams and external business partners to develop CMC regulatory strategies, identify regulatory risks, and propose options for risk reduction and/or risk-based approaches to achieve timely approvals
• Represents the department in cross-functional project teams
• Establish the framework for managing the preparation, authoring and maintenance of Quality-related regulatory submission documents for global clinical trial and marketing applications, as well as post-marketing variations.
• May require technical regulatory authoring, review, and/or approval  of submissions, responses to HA queries, HA engagement briefing packages, etc.
• Supports regulatory impact assessment of changes applicable to clinical and/or commercial programs, with consideration for product or program global regulatory strategy and/or business impact
• Provides expert review and/or guidance to team members and cross-functional partners in the preparation of CMC documentation supporting regulatory submissions and communications, enabling a right-first-time approach.
• Maintains knowledge and expertise of Global (major market) regulations and guidance to ensure regulatory compliance is maintained; considers evolving regulations, HA expectations, and Industry trends to enable flexible or risk-based approaches.
• Ensures conformance to commitments made with various regulatory agencies
• Provides regulatory advice to other functional areas. May participate in regulatory due diligence activities.

Relationships

This person will be the primary point of contact for regulatory CMC in Europe and other Global markets, while also building/maintaining a close partnership with US-based colleagues.
 

The successful candidate will be adept at developing and maintaining collaborative relationships with internal/external business partners, utilizing  effective communication to identify, resolve, and/or escalate issues and timelines.

Management

This is currently an Individual Contributor position; however, there is the possibility for supervisory responsibilities in the future.

Develops, provides training, and implements regulatory processes, procedures, and best practices within the team and cross-functionally.

Qualifications

• 15+ years of related work experience, including  12+ years in Regulatory Affairs CMC in the Biotech/Pharmaceutical industry; experience in small molecule drug development and life cycle management is required; experience in the cardiovascular therapeutic area is a plus. Extensive experience leading the planning, preparation, and execution of CMC/Quality related global submissions. Expertise in developing robust global CMC strategies, ensuring compliance with international regulatory requirements, and managing interactions with health authorities, including US FDA, EMA, and other global agencies, to secure product approvals. Regulatory expertise in small molecule drug substance is a plus.
• Proven experience with serving as a primary RA-CMC contact to Health Authorities with full strategic responsibility; participation and leading Health Authority engagement for CMC/Quality-specific and/or multidisciplinary meetings, including the US and EU. Other global HA interaction experience is a plus (e.g., Japan, China, Canada, LATAM, APAC, other RoW/MoW markets).
• Notable experience with cross-functional collaboration, team building and/or leadership, and navigating complex CMC challenges throughout the product lifecycle with consideration for business impact and priorities.
• Bachelor’s degree is required, preferably in chemistry or a closely related field; an advanced degree is preferred.
• Excellent working knowledge of global regulatory requirements,  trends/ hot topics, and environment, including an understanding of GXPs.
• Solid working knowledge of core processes associated with discovery, development, and manufacturing of small molecules.
• Experience with eCTD requirements and electronic submissions
• Experience with international regulatory submissions and processes is a strong plus. Ability to work effectively across teams, functions and with outside partners.
• Excellent oral and written communication skills Excellent organizational skills and attention to detail

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Pay Range:

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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

• We will never request personal information such as banking details until after an official offer has been accepted and verified

• We will never request that you purchase equipment or other items when interviewing or hiring

• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer