ABOUT US:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 750 high-quality generics, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

DESCRIPTION:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Associate Director, Regulatory Affairs to join our team. In this role, you will be responsible for leading the Columbus regulatory group in filing new multisource products that meets regulatory and manufacturing standards and ensures maintenance of lifecycle products. Working 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 regulatory filings. You will work closely with R&D Labs, Quality, Production, Regulatory Compliance, Engineering and Packaging.

QUALIFICATIONS:

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

EDUCATION:

Minimum: Bachelors, Masters, or advanced degree in a scientific discipline required
Preferred: RAC certification

EXPERIENCE:

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

SKILLS:

• Demonstrated experience communicating with 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 and external 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
• Deep and broad knowledge of regulatory affairs

• 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 and that internal policies and procedures, 21 CFR, FDA 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 FDA requirements/standards. Keeps current in the regulatory guidances, practices and technologies necessary for all regulatory submissions (labeling 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. Reviews and assesses the risk assessment of critical submissions and develops risk mitigation plan in order to ensure an expedient FDA approval.
• Predictable, onsite attendance required