11 days old

Regional Regulatory Strategist, Manager

Warsaw, IN 46580
**Regional Regulatory Strategist, EU/ Emerging Markets Rare Disease - Manager**


This role is the exciting opportunity to join Pfizer's Global Regulatory Affairs department. The ideal candidate will have EU/ Emerging Markets (EM)/ Global Regulatory Affairs experience, ideally encompassing the Rare Disease drug development lifecycle. This is an energetic and diverse Global Regulatory Affairs team and you would be working with colleagues locally and around the globe.

We have a clear purpose - Breakthroughs that change patients' lives . Our values and behaviours of 'Courage', 'Excellence', 'Equity', and 'Joy' create an organisational culture in which talent development plays a central part in attracting and growing the best Regulatory Affairs expertise.

**Role Responsibilities**


The major duties and responsibilities will include but are not limited to:

+ Function as the EU/ EM Regulatory Lead for assigned programs within Rare Disease. Primary point of contact for external EU Health Authority interactions and primary EU regulatory point of contact for internal stakeholders. Partners with project teams and other customer groups (e.g. Country Regulatory Managers and Commercial Teams) to ensure required regulatory contributions (CTA, MAA, variations, license renewals, Annual Reports, etc) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.

+ Contribute to Regional and Global Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s.

+ Ensure regulatory contributions achieve the objectives of the development strategy, achieve agreed standards, minimize resource demands whilst maximizing overall project delivery time and probability of success and facilitating post filing activities.

+ Ensure regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.

+ Ensure an aligned regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the business are championed and communicated.

+ Work closely with other Regulatory Strategists within and across sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.

+ Implement systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines

+ Ensure business compliance and implementation of and adherence to Regulatory standards.

+ Develop and maintains constructive working relationship with Health Authority contacts as appropriate.

**Organisational Relationships**

+ Reports to Global Regulatory Portfolio Lead (GRPL)

+ Works with internal Global Regulatory Affairs groups and relevant project teams. In addition, works with relevant development/commercial team representatives.

+ Partners with Regional, Medical, Regulatory and Commercial colleagues including, Country Regulatory Managers.

+ Works with external contacts in Regulatory Agencies, as well as relevant experts and key opinion leaders.

+ As needed works with other International Regulatory contacts.

+ Ensures alignment with Global Regulatory Lead and GRPL

**Qualifications, Skills and Experience**


+ Scientific Degree with a minimum of 3-6 years of experience in EU and Global regulatory affairs, preferably in human medicines.

+ Fluent English language skills both verbal and written

+ Proven ability to manage 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.

+ Demonstrable experience of effective delivery in a complex matrix environment.

+ Strong strategic thinking, project management, team working, problem solving, communication and interpersonal skills.

+ Knowledge of national/regional and global 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.


**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.


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 Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms - 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.

Regulatory Affairs



Posted: 2021-03-29 Expires: 2021-04-28

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Regional Regulatory Strategist, Manager

Warsaw, IN 46580

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