Director, Regulatory Affairs CMC Europe

Cytokinetics is a late-stage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

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

Management

Qualifications

#LI-HYBRID

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.

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Cytokinetics is an Equal Opportunity Employer

Required Experience :

Director

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full Time

Experience : years

Vacancy : 1