Manager - Regulatory Affairs

August 13, 2024

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KMR Executive Search

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KMR Executive Search is a recruiting firm that specializes in the Healthcare, Pharmaceutical, Biotech, and IT Services sectors. With a nationwide client base, KMR focuses on connecting qualified professionals such as nurses, physicians, and IT experts with rewarding job opportunities. The firm is dedicated to facilitating a seamless job search experience, ensuring candidates find satisfying roles that align with their career goals.

executive search • talent management • recruiting • interviewing • candidate research

2 - 10 employees

Founded 2017

💊 Pharmaceuticals

🧬 Biotechnology

📋 Description

• This position supports both their individual and overall departmental goals regarding the number of filings to be submitted and approved yearly. • Manage and assure the quality of the applications (ANDA, NDA, 505(b)2, etc.) that are filed on time. • Mentor and provide regulatory support and management to associates within the group and the organization. • Requires minimal to no supervision. • Manages department resources by providing guidance, coaching, and development opportunities through on the job experience, mentorship, and training. • Inspires and motivate team members to achieve departmental and functional goals. • Evaluates performance and provides specific, relative, and timely feedback to individuals to ensure consistency in regulatory practices. • Reviews technical regulatory content of original applications and amendments, and/or post-approval supplements (focus on CMC and Labeling) for the US market. • Regulatory submissions will be submitted to FDA as per the business needs and compliance with all FDA requirements. • Provides expert support as a regulator subject matter expert and work closely with cross-functional departments to provide the appropriate regulatory requirements/guidance. • Stays current with emerging regulatory guidance, and industry expectations and standards, and demonstrates the ability to translate these into process improvements or best practices. • Actively looks for ways to improve current processes within department and across the business to gain efficiency and quality submissions to US FDA.

🎯 Requirements

• Minimum of a bachelor’s degree required (Science related field) • Previous management experience in a Pharmaceutical company • Pharmaceutical experience a minimum of 8 years of regulatory submission experience • Excellent presentation skills, meeting facilitation skills, verbal and written communication skills with all levels of the organization • Ability to influence others by presenting alternative options persuasively • Negotiation skills with internal and external customers/government agencies • Strong project management skills with the ability to plan, organize, and multitask • Effectively processes thoughts quickly and accurately from one project to another • Creative problem solving and strategizing abilities especially as it pertains to the regulatory requirements for complex filings like combination products and transdermal • Broad knowledge of regulatory affairs • Ability to work independently and manage timelines/priorities without guidance or supervision • Attention to detail • Critical Thinking