Position: Senior Regulatory Affairs Specialist CMC
Location: Madison, NJ
Duration: 12 Months

NOTE: This position currently a hybrid work model with 3 days reporting on site in Madison, NJ and is planned to move to Rahway, NJ in 2Q 2023.

Responsibilities:

• 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 relevant 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.
• Provide regulatory assessment for post approval change proposals, 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 project 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.
• Performs other tasks as requested by management.

Education:

• Bachelor of Science degree (minimum) in science, engineering, or other relevant field (advanced degree preferred).
• Experience: At least 4 years of previous Regulatory CMC experience.
• Working 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.
• Proficient in English, high level of professionalism, experience reviewing scientific information, demonstrated oral and written communication skills.
• Demonstrated understanding of related fields (manufacturing, packaging, quality control, and quality assurance).
• Leadership skills (problem solver, ability to deal with multiple priorities.
• Strong interpersonal skills to collaborate with internal partners and liaise with regulatory authorities (CVM/FDA) as needed, sound judgement and attentive to details).