Manager, Regulatory Affairs

SUMMARY OF POSITION

• Plans, coordinates, authors and critically reviews submissions to FDA ensuring that internal consistency and consistency to relevant FDA guidelines are met. Submissions will include: Original 505(b)(2)s, pINDs, INDs, Meeting requests, ANDAs , Amendments, Supplements, Annual Reports, and other life cycle management activities.
• Works with project management, development, and commercial teams and leads 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.
• Ensures that regulatory files and data systems are maintained and in compliance with related work instructions and regulations.

ORGANIZATION STRUCTURE

The Manager, Regulatory Affairs reports into the Director Regulatory Affairs or above and is based in Morristown, New Jersey.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

1. With minimal supervision, prepares, compiles and files new , 505(b)(2), INDs, Meeting requests, ANDAs, Amendments, Supplements, and Annual Reports filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
2. Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.
3. Participates in the establishment of project plan due dates including pre-NDA or pre-ANDA activities and ensure that the due dates for milestones are met.
4. Ensures that change management activities for existing commercial products are executed properly and on-time.
5. 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.
6. Assists in promoting sound regulatory strategies in support of submission and approval goals.
7. Participates in project team meetings and provides regulatory acumen to staff and internal team members in support of complex and/or combination products.

QUALIFICATIONS

• Minimum of 7years in the pharmaceutical industry and a Bachelor's Degree in science -Or- 6 years in the pharmaceutical industry and a Master of Science (M.S.) in Regulatory Affairs or an equivalent advanced degree preferred
• No less than 5 years direct experience in Regulatory Affairs.
• Prior experience in 505(b)(2) submissions is preferred.

Job-Specific Competencies/Skills:

• 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.