about 1 month ago
Hamlyn Williams has partnered up with a company to hire an Associate Director/Director of Regulatory Affairs in Generics. The Associate Director/Director of Regulatory Affairs will be the Head of Pre-approval and oversee, direct, and manage the day-to-day activities of the Regulatory team at this company. They will be reporting directly to the senior Director.This position plays a key role in assuring that the proper regulatory pathways are established at the stages of both business development and commercial operations. Additionally, the position requires a willingness to “roll up your sleeves” and engage hands on in substantive regulatory work, as well as the ability to effectively work collaboratively with other departments. The Director will work closely with the Business Development, QA, Supply Chain, Sales, and Operations departments. The most attractive candidate would have experience in regulatory CMC. Ideally they would have experience with electronic submissions and regulatory operations submissions. Regulatory operations will be reporting into this role. This role will be a mentoring position. In addiction to technical skills, our client is looking for a candidate with great soft skills.
Essential Duties & Responsibilities:
- Responsible for achieving department objectives in preparation and submission of Abbreviated New Drug Applications and New Drug Applications, including amendments, supplements, annual reports, and related submission documents, obtaining information from all appropriate departments or outside suppliers.
- Responsible for interpreting regulatory guidance and proposing regulatory strategy to expedite approval of drug applications in accordance with agency requirements.
- Leverage a strong understanding of FDA guidance applicable to drug applications, and the ability to independently develop and execute efficient regulatory strategies.
- Reviews FDA correspondence regarding submissions and initiates necessary actions to ensure timely responses.
- Directs the development of new product pipeline approval submissions to meet FDA regulatory review requirements.
- Maintains approved ANDAs in compliance with FDA regulations with emphasis on strict maintenance of all annual reports and change controls.
- Responsible for final release to the market and field alert/recall decisions for ANDA owned products.
- Provides planning and leadership to staff by ensuring that appropriate structures, policies, competencies, and values are developed.
- Provides leadership in developing and implementing regulatory strategies and processes.
- Interfaces with customers regarding regulatory issues in support of business development and sales opportunities.
- Is key contributor to business development and sales teams providing compliance input to influence selection of partners and business decisions.
At LEAST a BS.
• Minimum 7-12 years’ experience in Regulatory Affairs, specifically in Generics
• Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence
• Proven experience of leading regional development, submission, and approval activities in local region(s). Capable of organizing and executing successful milestone meetings and with track record of successful relationships with one or more health authority
• Extensive knowledge of clinical trials (where relevant to generics) and licensing requirements
• Ideally also a significant external network at least into other generic/API/pharma companies and recognized as an expert broadly or in specific areas of regulatory affairs