Senior Regulatory Affairs Manager
Buckinghamshire, United Kingdom
About the Company
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry. Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
A Senior Regulatory Affairs Manager at Allergan supports the implementation of registration strategy for assigned products ensuring that a regulatory approval path is defined. You will work on products from early development phase to approved product’s lifecycle activities. You will be preparing lifecycle variation submissions, Scientific Advice dossiers, PIP dossiers and MAA submissions. As a Senior Regulatory Manager, at Allergan, you will lead agency discussions for your assigned products and contribute to cross functional teams to ensure a commercially successful product in the Europe region. We are looking for a RA professional with a good foundation of experience and who develops and maintains knowledge of the evolving European Regulatory landscape.
Essential duties and Requirements
• Provides appropriate regulatory input for the European region to project teams and Global Regulatory Teams.
• Responsible for ensuring effective planning, tracking, archiving of activities.
• Supports the communication of regulatory strategy in support of new product registration, in line with commercial objectives.
• Responsible for ensuring that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration.
• Drives and leads regulatory activities in support of lifecycle management and maintenance in the region.
• May be required to mentor less experienced staff as required
• Establishes strong and effective relationships with “in country” and global regulatory teams thereby ensuring RA activities are in line with regional business priorities.
• Follows core Global and Regional RA policies and procedures.
• Support development and implementation of new processes and ensure that these meet regional regulations and needs
• Responsible for ensuring forecasts for assigned projects are maintained and developed
• Follow all approved Allergan regional procedures and guidance
Qualifications, Education and Experience
• Graduate in Life Sciences in a relevant area.
• Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region.
• Prior relevant experience in pharmaceutical Regulatory Affairs in any of the following
- Innovative Pharma (NCEs, ATMPS, Biologics) regulatory strategy,
- Centralised Procedure, MRP or DCP,
- Scientific Advice procedures
Essential Skills and Abilities
• Demonstrated planning and organisation skills.
• Ability to prioritise and manage multiple projects.
• Good interpersonal and negotiation skills and the ability to influence others without formal authority.
• Excellent communication skills, both written and verbal (in English).
• Positive, can do attitude
• Computer literate (Microsoft Office Suite)