Senior Manager Regulatory Affairs Europe
vor 1 Tag
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.
Role Overview
Cytokinetics is seeking a Senior Manager, Regulatory Affairs Europe, to join the Regulatory Affairs team in Europe. He/she will assist the senior members of the EU regulatory team in developing and executing best-in-class regulatory strategies for assigned programs in the European region. The Senior Manager will contribute to all regulatory activities related to the submission of Marketing Authorization Applications of assigned Cytokinetics products in Europe (including UK and Switzerland) as well as implementation of post-marketing requirements.
The Senior Manager, Regulatory Affairs Europe, will support the EU regulatory team in ensuring all regional and local regulatory requirements are met and developing the regulatory processes related to the launch of Cytokinetics commercial products in the region. In this role, the Senior Manager will work closely with Global Regulatory functions as well as Commercial, Market Access and Medical Affairs functions in Europe.
The Senior Manager may lead independently certain projects as required.
Responsibilities
- Support the execution of the regulatory strategy and filing plans in Europe including effective planning, tracking, and archiving activities in line with corporate, regional and local business objectives.
- Ensure high-quality regulatory submissions are made on time and meet Cytokinetics requirements.
- Support product maintenance and lifecycle management activities, in line with regulatory requirements and regional business needs.
- Collaborate with the EU Regulatory Lead and the Regulatory Study Lead in EU-CTR aspects as required.
- Assist in the preparation of EMA/national agencies interactions.
- Maintain an awareness of new and developing legislation, regulatory policy and technical guidance relating to Cytokinetics products and support the EU Regulatory team in discussing their implications with business.
- Participate in regulatory-related launch and post-marketing activities in the EU as required.
- Work closely with the relevant functions on relevant regulatory procedures applicable to the European region.
Qualifications
- A minimum of 3-5 years of relevant experience with a sound knowledge of the pharmaceutical regulations and guidelines applicable within the European region.
- Demonstrated prior relevant experience in pharmaceutical Regulatory Affairs and managing regulatory procedures.
- Bachelor of Science in scientific discipline, Pharm D (/Pharmacist) or PhD preferred.
- Solid foundation in science obtained through academic and work experience.
- Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Strong interpersonal capabilities.
- Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
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.
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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