Regulatory Affairs Manager
Why Patients Need You
The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated colleagues like you who are experts in their field and can keep their well-being as their topmost priority.
What You Will Achieve
You will represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.
As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
It is your dedication and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Actively participate in Regulatory and cross functional global teams for assigned projects/products.
- Contribute to regulatory strategy and operational activities for projects/products, including preparing and submitting correspondence and applications to regulatory agencies.
- Lead in developing and implementing regulatory strategies that align with business needs, including projects and activities relating to clinical trials, registration procedures, maintaining registrations, product defense and regulatory compliance
- Direct and/or indirect liaison with Health Authorities (in conjunction with Country Regulatory Leads (CRLs)) to facilitate the prompt review and approval of applications, including clinical trial applications, marketing authorization applications, supplements/variations, and commitment closures
- Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the division.
- Maintain licenses in compliance with local regulations by ensuring that corporate regulatory processes, Standard Operating Procedures (SOPs) and systems are in place.
- Manages the compilation for core package build, contributing to (Clinical Trial Application) CTA and authoring documentation.
- Update and check recorded/newly entered data regularly and in timely manner according to the standard operation procedures/guidelines.
- Bachelor's Degree in a in a science subject
- Good level of experience
- Experience in Over the Counter or pharmaceutical industry, with experience in the global regulatory environment
- Regional/Country regulatory experience including submission processes and product life cycle management activities
- Ability to manage complex issues with appropriate support, such as global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management or leveraging regulatory policy issues to support commercial objectives
- Knowledge of commercial activities and Current Good Manufacturing Practices (part of GxP)
- Ability to work well cross functionally and to develop productive/collaborative relationships
- Strong problem-solving abilities, plus written and verbal communication skills
- Experience in successfully communicating with Health Authorities
- Relevant pharmaceutical experience
- Experience of conducting, managing or participating in the audit process
Ideal location for candidates would be in Tadworth, Surrey with flexible working - however, we are open to offer the right candidate a fully remote role