Manager, Regulatory Affairs

Overview

This position supports both their individualand overall departmental goals regarding the number of filings to be submittedand approved yearly by planning, managing and assuring the quality of theapplications (ANDA, NDA, 505(b)2, etc.) that are filed on time, and respondingto subsequent deficiencies completely and on time. The candidate will beexpected to mentor and provide regulatory support and management to associateswithin the group, as well as within the organization. Requires minimal to nosupervision.

Responsibilities

Managesdepartment resources by providing guidance, coaching, and developmentopportunities through on the job experience, mentorship, and training. Inspiresand motivates team members to achieve departmental and functional goals.Evaluates performance and provides specific, relative, and timely feedback toindividual to ensure consistency in regulatory practices.

Reviewstechnical regulatory content of original applications and amendments, and/orpost-approval supplements (focus on CMC and Labeling) for the US market. Regulatory submissions will be submitted to FDA as per the business needs andcompliance with all FDA requirements.Providesexpert support as a regulator subject matter expert and work closely withcross-functional departments (i.e. Quality Assurance, Quality Control,Technical Services, Product Development, Analytical Development, ProjectManagement etc.) to provide the appropriate regulatory requirements/guidance,as applicable.

Support will also be provided to cross functional teams for applicablesubmissions to US FDA.Stayscurrent with emerging regulatory guidance, and industry expectations andstandards, 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.

Qualifications

Education Required:

Minimum of a bachelor’s degree required(Science related field)

Experience Required:

• Previous management experience in aPharmaceutical company
• Pharmaceutical experience a minimum of 8 yearsof regulatory submission experience

Core Competencies:

Excellent presentation skills, meetingfacilitation skills, verbal and written communication skills with all levels ofthe organization Ability to influence others by presentingalternative options persuasively Negotiation skills with internal and externalcustomers/government agencies Strong project management skills with the abilityto plan, organize, and multitask Effectively processes thoughts quickly andaccurately from one project to another Creative problem solving and strategizingabilities especially as it pertains to the regulatory requirements for complexfilings like combination products and transdermal Broad knowledge of regulatory affairs Ability to work independently and managetimelines/priorities without guidance or supervision Attention to detail

Critical Thinking

Job-Specific Competencies:

Comprehensive understanding and expertknowledge of regulatory requirements for pre-approval submissions for the USMarket.

Expert understanding of regulations andrequirements for US market through expert knowledge, FDA Guidance Documents andMAPPs, ICH Guidelines, Code of Federal Regulations as they pertain to genericdrug products.

• Consistently demonstrates the ability toensure high quality submissions to US FDA.
• Originally posted on Himalayas