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 Describe briefly the major activities of the position. Indicate the approximate... more details
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 Describe briefly the major activities of the position. Indicate the approximate percentage of time spent on each activity.
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
Education:
Bachelor of Science degree (minimum) in science, engineering, or other relevant field (advanced degree preferred).
Experience:
At least 2 years of relevant experience (for example: pharmaceutical research, manufacturing, or quality), 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). Previous CMC experience is required.
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