Associate Director Regulatory Affairs

The Associate Director, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care products in North and South America assigned to their direct reports. He/She will be responsible for reviewing all submissions compiled by their direct reports prior to dissemination to Health Authorities, country distributors or external partners. The Associate Director will act as the regulatory representative on multi-disciplinary product and project teams, providing advice on regulatory activities and communicate regulatory requirements, execution pathways and strategies to the Project Team including authoring of Regulatory Strategy Documents (RSDs).

Key Roles/Responsibilities:

The Regulatory Affairs Associate Director is responsible for providing leadership and guidance to a team comprising of Regulatory Affairs Associates and Managers, some of which are located internationally.

Essential job functions include but not limited to:

• Interpret regulations, guidelines, and compliance requirements and communicate them to other team members and departments within the organization while demonstrating a high ability to make appropriate decisions.
• Act as regulatory representative on multi-disciplinary product and project teams, providing advice on regulatory activities and communicate regulatory requirements, execution pathways and strategies to the Project Team including authoring of Regulatory Strategy Documents (RSDs).
• Work closely with internal manufacturing sites and external manufacturing organizations to assess post-approval product chemistry, manufacturing and control (CMC) changes and determine appropriate global filing strategy.
• Manage the assembly, compilation and review of documentation for product compliance, registration and life cycle maintenance.
• Maintain up-to-date knowledge of data requirements, applicable SOPs, policies, regulations, guidelines, and industry standards. Knowledge areas include ICH, WHO, GMP, USP, stability, validation, and US, EU and International regulations.
• Communicate with global regulatory agencies and distributors/customers as directed.
• Responsible for reviewing all submissions compiled by direct reports prior to dissemination to Health Authorities, country distributors or external partners.
• Demonstrate excellent oral and written communication skills, including editing of documents prepared by others for regulatory submissions.
• Participate in review and evaluation of regulatory compliance of document changes (product, process, test method, validation, etc.)
• Evaluate business opportunities and perform regulatory due diligence for in-licensing and product acquisition for assigned region.

Essential Qualifications:

• BS, B Pharm, Pharm D. or MS in scientific discipline or equivalent education; Master’s degree preferred. 10-12 years’ in a pharmaceutical environment with at least 8 years’ regulatory affairs CMC experience. Must also have a minimum of 7 years’ experience managing direct reports.
• Additionally, must have previous experience developing complex regulatory strategies for multiple products or multiple regions.
• Knowledge of global regulatory filings preferred. Medical Device experience also preferred.

Essential Experience:

• Must possess ability to develop complex regulatory strategies for products registered in multiple regions. Possess ability to effectively multi-task, establish priorities and mentor more junior regulatory staff while working in a fast paced environment.
• Must demonstrate leadership skills and ability to interact with senior management.
• Possess excellent written and verbal communication skills since some direct reports are located internationally.
• Expert knowledge of the pharmaceutical business and proficiency at interpreting regulatory guidelines to convey regulatory options while supporting strategic business objectives.
• Must have thorough understanding of technical and scientific information to advance project goals (CMC SME).