Regulatory Affairs Associate

3 weeks ago

South San Francisco, United States Cytokinetics Full time

Reporting to the Senior Director of Regulatory Affairs, the Regulatory Affairs Associate is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects.

**Responsibilities**
- Prepare and/or coordinate and comply routine regulatory submissions and other correspondence in accordance with regulatory agency regulations and guidelines
- Review regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements
- Interface with functional areas (CMC, Nonclinical, Clinical) to obtain information required for regulatory submissions
- Assist with creating and maintaining regulatory timelines and tracking deliverables to ensure regulatory submission timelines are met
- Assist with preparation for global regulatory team and subteam meetings
- Develop and maintain tracking logs for regulatory activities
- Monitor regulatory environment for changes to requirements
- Support regulatory team through research on evolving regulatory issues, overall product landscape, etc, including searches of the relevant literature
- Maintain current knowledge and expertise of FDA/EMA regulations and ICH guidelines
- Collaborate with other functional areas in preparing and maintaining SOPs and appropriate regulatory operating guidelines
- Assist with regulatory due diligence and inspection readiness activities

**Qualifications**
- Bachelor's degree in biology, chemistry, or related discipline with 2+ years' experience in regulatory affairs or drug development preferred
- RAC certification a plus
- Ability to work effectively across teams, functions and with outside partners
- Ability to prioritize and handle multiple competing tasks
- Excellent oral and written communication skills
- Excellent attention to detail with solid coordinating, task planning and time management skills**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

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