Director of Regulatory Affairs

Director of Regulatory Affairs at LHH Director of Regulatory Affairs at LHH in Middlesex, New Jersey Posted in about 20 hours ago.

Type:

full-time

Job Description:

Director of Regulatory Affairs The Director of Regulatory Affairs is responsible for leading the execution of regulatory strategies across both development-stage and commercial product portfolios. Reporting into senior regulatory leadership, this role acts as the primary regulatory representative on cross-functional teams, guiding strategic planning and ensuring successful execution of key program objectives. This position plays a critical leadership role in managing the day-to-day activities of the regulatory function. Responsibilities include overseeing active regulatory filings and ensuring the delivery of high-quality, timely submissions to global regulatory authorities, with a primary focus on U.S. requirements. The role also involves coordinating global regulatory activities in collaboration with internal stakeholders, external partners, and regional vendors. Key Responsibilities Drive the implementation of regulatory strategies aligned with product development and lifecycle goals Lead daily regulatory operations, including submission planning, publishing, promotional review, and continuous process improvement efforts Serve as the regulatory lead on cross-functional teams, providing strategic guidance to R D, Clinical, Quality, and Operations groups Identify and communicate regulatory risks and provide recommendations to support informed decision-making Ensure alignment between project team activities and the overall regulatory strategy Act as the primary liaison with regulatory authorities for assigned programs Lead the preparation of regulatory submissions and responses to health authority inquiries across U.S. and international markets Coordinate cross-functional efforts to support regulatory milestones and submissions Review and contribute to technical documentation supporting regulatory filings Author and manage original applications and lifecycle submissions, including investigational and marketing applications and associated amendments Oversee regulatory deliverables such as annual reports, supplements, expedited program requests, and pediatric development plans Manage regulatory activities for assigned programs to ensure adherence to timelines and compliance requirements Qualifications Bachelor's degree in a scientific discipline required; advanced degree or regulatory certification preferred Approximately 10-15 years of regulatory affairs experience within pharmaceutical or biotechnology environments Strong knowledge of global regulatory frameworks, including U.S. and ICH guidelines; additional international experience is advantageous Demonstrated leadership experience with the ability to influence and guide cross-functional teams Solid project management capabilities with the ability to manage multiple priorities Strong communication skills with experience interacting with senior leadership and external stakeholders Proven ability to assess and mitigate regulatory risks Highly organized, detail-oriented, and adaptable in a fast-paced environment Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance