Manager, Regulatory Affairs

Proclinical, in support of our client, are seeking an individual to fill the role of Manager of Regulatory Affaris, based in New Jersey. The successful candidate will manage a team of Regulatory Associates and/or Senior Regulatory Associates in 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.

Responsibilities

• Prepare and compile relevant filings, ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Review documentation intended for submission to the FDA.
• Coach and direct team and provide development opportunities for team to reach their full potential.
• Establish project plan due dates and ensure that the due dates for milestones are met.
• Ensure that change management activities for existing commercial products are executed properly.
• Interface 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.
• Assist in promoting sound strategies in support of submission goals.
• Monitor, analyze and raise awareness and assess impact of regulatory issues for stakeholders inside and outside of regulatory affairs.
• Communicate regulatory requirements and strategies as they affect regulatory submissions to internal and external partners.
• Participate in project team meetings and provides regulatory acumen to staff and internal team members in support of projects.

Skills And Qualifications

• BA or higher in a related scientific field, and 7+ years of relevant experience, 5 of which within regulatory affairs.
• Prior experience in the generics industry preferred.
• Possess advanced analytical skills with the ability to interpret data/information and its practical application.
• Demonstrate in-depth knowledge and understanding of FDA guidelines and federal regulations with demonstrated ability to successfully apply these to a compliant work output.
• Strong critical and logical thinker with ability to analyze problems.
• Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity.
• Excellent written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kyle Weber at (+1) 646-367-2618 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-KW1