Job

Sr. Manager, Regulatory Affairs CMC

Responsibilities:

• Responsible for preparing, submitting, and maintaining regulatory filings for domestic and international regions, coordinating submission activities with internal team members and external parties (e.g., regulatory bodies; vendors; consultants), maintaining up-to-date information on regulatory requirements and product submissions
• Participate as Regulatory CMC representative in CMC project-related team meetings; will involve multiple CMC projects (investigational and commercial)
• Work with regulatory therapy area lead and SMEs on preparing the regulatory submission strategies, authoring and review of the submission content, creating and maintaining submission timelines in order to meet business objectives
• Capable of leading and coordinating the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation necessary for timely submissions
• Work with SMEs to provide timely responses to CMC questions from regulatory agencies
• Keep up to date on industry and regulatory trends as well as CMC-related regulatory requirements and/or national law, and communicate with CMC team

Preferred Experience and Skills:

• Bachelor’s degree in a scientific discipline; advanced degree preferred (MS, PhD)
• 9+ years pharmaceutical industry experience with minimum of 5 years of regulatory CMC experience
• Experience in the preparation and management of high quality CMC regulatory submissions for investigational and/or commercial products; must be a self-starter and capable of working independently
• Demonstrate understanding of small molecule CMC attributes and pharmaceutical development process of new molecular entities
• Solid knowledge of U.S. regulations and guidelines; experience with European regulations and guidelines desirable
• Possess excellent organizational skills; experience must include ability to effectively interact with research functions, QA, manufacturing, and analytical teams at all levels
• Strong analytical and problem-solving skills; must have excellent written, verbal, and interpersonal communication skills; attention to details and technical content is essential
• Ability to prioritize and manage multiple projects and tasks in a fast-paced biopharmaceutical company, and to adapt rapidly should strategy and unanticipated changes occur

Applicants must be currently authorized to work in the United States on a full-time basis.