Manager, Regulatory Affairs, Pipeline Products

Job Description

The Manager, Regulatory Affairs is accountable for the preparation, coordination, and management of global regulatory submissions and work with senior regulatory personnel to develop regulatory strategies. This individual will have experience with submission and management of global clinical trial applications, including INDs.

• Actively contribute to the development and implementation of regulatory strategy with regulatory senior management to define regulatory strategies
• Coordination and prepare regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.)  to meet corporate strategy & timelines
• Provide regulatory input into cross-functional Project Teams for product development
• Provide regulatory review of internal documentation supporting product development activities (e.g. clinical protocols, clinical study reports, etc.)
• Provide regulatory input into project teams in partnership with senior regulatory management as required to provide technical guidance & to assist in problem solving/issue resolution etc.
• Work cross-functionally with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
• Assist in communications with Regulatory Agencies
• Monitor company progress toward fulfillment of regulatory commitments
• Remain current on regulatory requirements (e.g., Domestic and International) supporting the regulatory strategy and clinical operations related activities.)

Qualifications

• Experience in submission writing and review experience essential
• Experience with combination (drug/device) products a plus
• Experience of direct interaction with Regulatory Agencies also a plus      
• Bachelor’s or Master’s degree in a scientific discipline or equivalent. Regulatory Affairs Certification is preferred
• Candidate must possess at least 5  years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility.
• Must have experience with creating and managing INDs/CTAs, Annual reports/DSURs, and IND/CTA information amendment submissions. Experience supporting marketing authorization applications (e.g. NDA, NDS and MAA) a plus. Must have experience with electronic format (eCTD) submissions
• Strong interpersonal and written/verbal communication skills essential
• Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter
• High ethical standards for compliance to regulations and procedures is essential
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
• Must have excellent communication skills (verbal and written). 
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness. 
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Must successfully exhibit Insmed’s values; Collaboration, Accountability, Passion, Respect, Integrity; along with any other position specific competencies. 
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
• Travel requirement of approximately 10%; some travel may be international in scope.