Title:  Associate Director, Regulatory Affairs

About the Job

Leads the Zagreb regulatory group in filing new multisource products that meet regulatory CMC, Labeling and Publishing Standards and ensures maintenance of lifecycle products. Works closely with Senior Management on all issues surrounding filings in order to obtain approvals for new products as quickly as possible.  Ensures that regulatory requirements for both development and lifecycle products are completed on time and in compliance with FDA, ICH, and any other country specific regulatory requirements. Ensures development of robust regulatory strategies in order to comply with the rigorous requirements for both the FDA and other international agencies, as applicable.  Works with cross-functional leadership to help lead the planning and implementation of global regulatory filings for Hikma multisource products. Monitors and assesses impact of relevant global regulations and guidances on current US (and other health authority) regulatory filings. 

Key Responsibilities

• Manages, assigns, and critically reviews all incoming work amongst the team. Manages the planning, writing, and reviewing of all regulatory submissions. Writes and reviews clear, concise and accurate responses to inquiries from the FDA resulting from their review of these submissions. Manages and oversees GDUFA budget. 

• Evaluates performance, provides coaching, and ensures direct reports are developing appropriate skills to meet the needs of the business. Ensures right first time compliance with regulatory submissions made to the FDA/other Health Authorities and that internal policies and procedures, 21 CFR, Health Authority guidances, and other customer requirements are met.

• Recognizes issues and potential barriers, defines problems, identifies underlying principles, reasons, or facts, determines appropriate solutions, and utilizes resources to drive improvements of medium to high complexity. Develops a comprehensive regulatory strategy that takes into account both US and worldwide regulatory requirements to drive product filings, global registration (if applicable), achievement and maintenance of desired labeling, and effective regulatory agency interactions.

• Participates in outside focus meetings with internal groups as well as the FDA and other regulatory authorities in order to stay ahead of the changing regulatory environment. Identifies, develops, and implements new ideas and process improvements in order to ensure our filings are meeting the constantly changing Health Authority requirements/standards. Keeps current in the regulatory guidances, practices and technologies necessary for all regulatory submissions (CMC, Labeling, and Publishing included) as appropriate through training, seminars and investigating new technologies, and brings this information back to the relevant groups to effect change. Provides education and training on regulatory strategies and compliance issues to other functions.

• Coordinates and facilitates activities with other internal departments within Hikma to establish local policies and procedures for all regulatory filings which include review, submission and approval for all ANDAs, NDAs, supplements, and Annual Reports sent to the FDA (and equivalent submissions globally, as applicable). Reviews and assesses the risk assessment of critical submissions and develops risk mitigation plan in order to ensure an expedient Health Authority approval.

• Labeling Specific:  Leads labeling strategies and leads/contributes to presentations on labeling related topics internally and externally.  Contributes to continuous improvement initiatives and reviews/comments on related emerging regulatory guidelines/requirements.  Ensures that all required internal and external timelines and deadlines are met appropriately.

• Publishing Specific:  Leads the production of high-quality submissions utilizing submission-ready documents that adhere to internal and external electronic guidelines.  Ensures submissions meet the level of integrity required for Hikma and health authority validation tools.  Assists submission project teams with the identification of submission-ready content requirements and applicable timeline milestones for execution of right-first-time submissions

What We Expect

• Bachelors, Masters, or advanced degree in a scientific discipline required;

• Minimum of 6 years of increasingly responsible regulatory experience in the pharmaceutical industry; minimum 5 years leadership experience

• Demonstrated experience communicating with Health Authorities, including the FDA, and leading/motivating a team to meet regulatory deadlines

• Strong presentation skills, meeting facilitation skills, verbal and written communication skills

• Ability to influence others by presenting alternative options persuasively

• Negotiation skills with internal teams and with 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, as well as considerations for Labelling and Publishing.

What We Offer

• A dynamic work environment

• Opportunities to interact with colleagues at all levels, as well as clients and customers

• 30 vacation days per year

• Annual health check-up

• Monthly food and travel allowances