Senior Regulatory Affairs Lead – UK/EU, London

Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all stakeholders. PCC maintains a wide presence across the US, Europe, and more than 100 countries globally. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane, and Halothane as well as Intrathecal Baclofen therapy for spasticity management. PCC has strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators.

Job Summary:

Team lead and responsible for regulatory integration of Kenalog product line.

Key Stakeholders – Internal:

• Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Program Management, Senior Management

Key Stakeholders – External:

• Country Distributors, Health Authority (HA), external partners

Essential Duties and Responsibilities:

• Responsible for taking ownership of Kenalog marketing authorization transfer activities (MATs) and providing regulatory guidance to the global cross-functional team.
• Interpret regulations, guidelines, and compliance requirements (especially for the UK/EU region) and communicate them to other team members and functionalities/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 communicating regulatory requirements to the Project Team on Kenalog MATs.
• Develop and ensure execution of Regulatory Strategy Documents (RSDs) as required to align with business requirements.
• Maintain up-to-date knowledge of data requirements, applicable SOPs, policies, regulations, guidelines, and industry standards.
• Communicate with global regulatory agencies and distributors/customers as directed.
• Assess post-approval product chemistry, manufacturing and control (CMC) changes and determine appropriate global filing strategies for Kenalog.
• Manage the assembly, compilation, submission and electronic publishing (if required) of documentation for product compliance, registration and life cycle maintenance for Kenalog products.
• Demonstrate excellent oral and written communication skills, including editing of documents prepared by others for regulatory submissions.
• Lifecycle management of centralized filing documents for Kenalog.
• Ensure global compliance of product labeling with inputs from team members.
• Maintain regulatory files/database, chronologies and HA contact reports.
• Participate in review and evaluation of regulatory compliance of document changes.
• Participate in research and dissemination of issues and information to cross-functional team as necessary for Kenalog.
• Train and mentor junior team members as required to better support business requirements.

Key Competencies:

• Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers.
• Excellent verbal and written communication skills.
• Creative and able to present various solutions.
• Energetic, enthusiastic and motivational disposition.
• Maintain confidentiality.
• Coaching skills.

Education / Experience:

• Requires a B.S. degree in a science or related field.
• M.S. and/or RAC preferred.
• Knowledge of US, UK, EU, and International regulatory requirements with an emphasis on UK and EU.
• Knowledge of Advertising and Promotional regulations highly preferred.