Sr Specialist, Regulatory Affairs CMC

Sr Specialist, Regulatory Affairs CMC

Job Location:

Rahway NJ 07065

Onsite Requirements:
CMC experience or R & D experience preparing the reports that feed into the CMC section (a quality background could be transferrable)
Experience authoring technical reports and regulatory submissions, experience reviewing scientific information, with sound judgement and attention to detail
Demonstrated understanding of cross functional relationships across the business (manufacturing, packaging, QC & QA as well

Job Description:

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)