Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Plans, coordinates, authors and critically reviews submissions to FDA ensuring that internal consistency and consistency to relevant FDA guidelines are met. Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files. Ensures that all due dates for regulatory milestones, in support of both pre and post-approval submissions, are met. Works on and solves increasingly complex projects/problems where analysis of the situation or data requires evaluation of some intangible factors. Ensures that regulatory files and data systems are maintained and in compliance with related work instructions and regulations.
The Manager, Regulatory Affairs reports into the Director/Associate Director Regulatory Affairs and is based in Pine Brook, New Jersey. Manages team of 1-3 direct reports.
Primary responsibilities of this role include the following:
- Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
- Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.
- Coaches & directs team to produce excellent work; provides development opportunities for team to reach their full potential.
- Participates in the establishment of project plan due dates and ensure that the due dates for milestones are met.
- Ensures that change management activities for existing commercial products are executed properly and on-time.
- Interfaces with project team members and functional departmental representatives to obtain documentation and establish timelines to ensure that complete and accurate submissions are prepared according to plan.
- Assists in promoting sound strategies in support of submission goals.
- Participates in project team meetings and provides regulatory acumen to staff and internal team members in support of projects.
- Minimum of a Bachelor’s Degree in a life science. A Master of Science (M.S.) in Regulatory Affairs or an equivalent advanced degree preferred.
- Minimum of 7 years in the pharmaceutical industry with 5 of those years in regulatory affairs with at least 2 years of supervisory/managerial experience.
- Prior experience in the Generics industry preferred.
- Excellent verbal and written presentation and communication skills are necessary.
- Possesses advanced analytical skills with the ability to interpret data/information and its practical application.
- Demonstrates in-depth knowledge and understanding of FDA guidelines and federal regulations with demonstrated ability to successfully apply these to a compliant work output.
- Monitors, analyzes and raises awareness and assesses impact of regulatory issues for stakeholders inside and outside of regulatory affairs.
- Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
- Strong critical and logical thinker with ability to analyze problems.
- Effectively communicates regulatory requirements and strategies as they affect regulatory submissions to internal and external partners.
- Consistently exercises sound judgement. Demonstrates an advanced ability to make appropriate decisions on regulatory activities and work outputs. Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
- Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity.