What are the responsibilities and job description for the Sr. CMC Regulatory Affairs Specialist position at Kelly Science, Engineering, Technology & Telecom?
SUMMARY OF POSITION
The Senior Specialist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Senior Specialist is also responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products.
MAJOR ACTIVITIES AND RESPONSIBILITIES
- Work independently and effectively with other functions to manage and prepare regulatory CMC dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country in order to gain new and maintain existing product registrations
- Review active substance master files, CEP dossiers and all supporting technical documents for suitability for use in regulatory submission.
- Provide regulatory filing strategies and timelines to active substance suppliers in collaboration with the team, help identify risks, and propose mitigation strategies as needed?
- Assess post approval changes, provide regulatory filing strategies and timelines, identify risks and propose mitigation strategies
- Ensures important submissions/tasks are completed on a timely basis
- Actively participate on new product development teams as well as other types of teams and initiatives and deliver on all assigned regulatory milestones
- Maintain regulatory information in accordance with processes and procedures to support regulatory compliance
- Continuously build and share knowledge of CMC related regulations and guidelines (including but not limited to FDA-CVM, EMA, and VICH), authority expectations, as well as current industry standards
- Identify and communicate potential regulatory issues to management, as needed.
Education: Advanced Degree preferred; minimum BS degree in science, engineering, or other relevant field
Experience:
- Degree plus experience and at least 2 years of experience in CMC
- Proficient in English, high level of professionalism, experience reviewing scientific information, demonstrated oral and written communication skills, demonstrated understanding of related fields (manufacturing, testing, and quality assurance), leadership skills (problem solver, ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details).
