Head of Regulatory Affairs West Europe Cluster
Lead, manage and provide strategic direction to the cluster/country regulatory team in France, Belgium/Luxembourg and Netherlands. Accountable for all strategic regulatory activities for the cluster/country including pre- and post-authorisation product lifecycle activities and delivery of operational regulatory activities in partnership with above-country operational hubs.
Possible location for the role only in these 3 countries : France, Belgium or Netherlands.
- Deliver cluster/country strategic priorities and operational plans to budget and support delivery of regional regulatory objectives. Provide regulatory guidance/input into global and regional product development and regulatory strategies.
- Accountable for effective relationships with the local Regulatory Authority and representing the company at the regulatory committee(s) of the national Trade Association(s).
Leadership and Strategic Role
Lead and manage the cluster/country team in the development of regulatory strategies for registration of new products and line extensions, and their lifecycle management. Ensure that the team provides input into global and regional development and regulatory strategies to provide optimal support for meeting regional and cluster/country business objectives. Responsible for the leadership, development, and performance management of the cluster/country team to achieve company objectives and culture. Develop and enhance the capabilities and capacities of the team through the identification and implementation of training and development needs. Ensures that all regulatory activities in the cluster/country are managed in compliance with Pfizer standards and international/local regulations.
Develop strong partnerships within the cluster/country (e.g. Country Managers, Medical, Marketing, Supply Chain), and above-country functions (e.g. Global CMC, Global Regulatory Operations, Global Regulatory Affairs Therapeutic Area and Regional Teams) to facilitate the development and implementation of regulatory strategies to expedite the registration of new products, line extensions and life-cycle optimization. Provide strategic contribution to the country or cluster markets that support leadership team – anticipate what Regulatory needs to contribute to achieve business objectives, e.g. Business Unit Strategic and Operating plans.
Ensure internal regulatory processes and procedures are well documented and support compliant regulatory activities. Assure local licenses in country(ies) under responsibility are maintained (e.g. Marketing Authorizations) in compliance with local regulations and following corporate policies, regulatory processes, SOPs and keeping the systems updated (e.g. CMC change control, product labelling, etc.)
Oversight of local Regulatory Authority approvals for Pfizer sponsored Clinical Trials and the maintenance of approved Clinical Trial Applications.
Responsible for developing and enhancing relationships with key external entities (Regulatory Authorities, Boards of Health, regulatory key opinion leaders, etc.). Manage the Health Authority interface throughout the product development and product lifecycle, developing a long-term and positive relationship characterized by Integrity, Quality, Compliance and Leadership. Represents the Company at the local Regulatory Authority(ies). Partner with Regulatory Policy to develop and reinforce Pfizer regulatory positions with external stakeholders and understanding of the external environment. Understand local regulations and developing trends in the local regulatory environment of the countries under responsibility and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies, and decision making. Influence on new legislation initiatives that could impact the business. Active participation in the local Trade Association(s) and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business.
Qualifications / Skills
- Scientific Degree – such as life sciences or chemistry. Pharmacist degree may be mandatory in some countries.
- A higher degree (MSc, MBA or PhD) may be an advantage but is not essential in most countries. Extensive experience in regulatory affairs, preferably in human medicines. Proven ability to manage complex regulatory issues.
- Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
- Proven ability to consistently deliver to time, cost and quality standards.
- General management experience and previous line management and leadership experience at senior management level is essential.
- Demonstrable experience of effective delivery in a complex matrix environment.
- Strong leadership qualities and management skills, including talent development, team working, problem solving, communication and interpersonal skills.
- In depth knowledge of national/regional regulatory legislation and guidelines. Understanding of business and financial environment, drug development process and the pharmaceutical industry.
- Knowledge and understanding of quality systems, processes, audit and inspections.
- Ability to influence at all levels in the organization and build networks internal and externally.
Reports to the Head of Regulatory Affairs EuCANZ (Europe, Canada, Australia and New Zealand), Global Regulatory Affairs—International.
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Opportunity Employer
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.