Manager, Regulatory Affairs

Regulatory Affairs Manager

This position supports both their individual and overall departmental goals regarding the number of filings to be submitted and approved yearly by planning, managing and assuring the quality of the applications (ANDA, NDA, 505(b)2, etc.) that are filed on time, and responding to subsequent deficiencies completely and on time. The candidate will be expected to mentor and provide regulatory support and management to associates within the group, as well as within 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 motivates team members to achieve departmental and functional goals. Evaluates performance and provides specific, relative, and timely feedback to individual 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 (i.e. Quality Assurance, Quality Control, Technical Services, Product Development, Analytical Development, Project Management etc.) to provide the appropriate regulatory requirements / guidance, as applicable. Support will also be provided to cross functional teams for applicable submissions to US FDA.

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.

Education Required : Minimum of a bachelor's degree required (Science related field)

Experience Required : Previous management experience in a Pharmaceutical company. Pharmaceutical experience a minimum of 8 years of regulatory submission experience.

Core Competencies : 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.

Job-Specific Competencies : Comprehensive understanding and expert knowledge of regulatory requirements for pre-approval submissions for the US Market. Expert understanding of regulations and requirements for US market through expert knowledge, FDA Guidance Documents and MAPPs, ICH Guidelines, Code of Federal Regulations as they pertain to generic drug products. Consistently demonstrates the ability to ensure high quality submissions to US FDA.