Director, Regulatory Affairs CMC Europe

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

Reporting to the Executive Director, Regulatory Affairs - CMC, the Director of Regulatory Affairs-CMC is responsible for leading regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international regulatory submission strategies.

Responsibilities

• Formulate CMC regulatory strategies, without supervisor oversight, based on current regulatory intelligence.
• Collaborates with cross-functional project teams and external business partners to develop CMC regulatory strategies and identify regulatory risks; represents the department in cross-functional project teams.
• Identifies the required documentation and any content, quality and timeline issues for global submissions and manages the delivery of approved technical documents in accordance with project timelines.
• Manages the preparation, authoring and maintenance of regulatory submission documents pertaining to CMC data for global clinical trial and marketing applications, as well as post-marketing variations. May require technical regulatory authoring of submission package components.
• Supports the evaluation of manufacturing changes for the potential impact on products.
• Provides expert review of CMC documentation supporting regulatory submissions and communications.
• Coordinates preparation of responses to queries from regulatory authorities, particularly focused on CMC. May require technical regulatory authoring to support responses to queries.
• Maintains knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs.
• Ensures conformance to commitments made with various regulatory agencies (e.g., IND/CTA commitments) for assigned programs.
• Provides regulatory advice to other functional areas.
• May participate in regulatory due diligence activities.

Relationships

• Build and maintain collaborative relationships with internal/external business partners to achieve project regulatory goals.
• Develops and maintains collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines.
• Develop and manage relationships with external vendors and regulatory health authorities.
• Coordinates activities for meetings and conferences with FDA, EMA, and other regulatory authorities
• Collaborate with regulatory colleagues to provide CMC expertise as needed.

Management

• This is an Individual Contributor position; however, there is the possibility for supervising consultants/contractors and/or interns.
• Develops and implements regulatory operating guidelines and common work practices/strategies within the team.

Qualifications

• 10 - 12+ years of related work experience (Director candidates will typically bring 12+ years; Associate level candidates may be considered with 10+ years and strong potential), including 8+ years in Regulatory Affairs CMC in the Biotech/Pharmaceutical industry; experience in small molecule drug development required; experience in the cardiovascular therapeutic area is a plus
• Proven experience serving as a primary RA-CMC contact to Health Authorities, with full strategic responsibility.
• Bachelor’s degree is required, preferably in chemistry or a closely related field; advanced degree is a plus.
• Advanced degree is preferred.
• Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
• 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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