Sr. Manager, Regional Regulatory Strategist
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Sr. Manager, Regional Regulatory Strategist
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Use Your Power for Purpose
At Pfizer, we're dedicated to bringing medicines and vaccines to the world faster without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your commitment and expertise are vital in expanding and accelerating patient access to Pfizer's medicines and vaccines.
Use Your Power for Purpose
At Pfizer, we're dedicated to bringing medicines and vaccines to the world faster without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your commitment and expertise are vital in expanding and accelerating patient access to Pfizer's medicines and vaccines.
WHAT YOU WILL ACHIEVE:
The purpose of this role is to
* Represent a particular region (EU) for the vaccines team in the global regulatory sciences organization
* Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST) level (if one in place)
* Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.
* Be accountable for timely submissions and approvals with commercially attractive labelling in the designated region
* Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s) within designated region.
* Role can be combined with other Regulatory Role(s) (i.e. Global Regulatory Lead).
* Project(s) assigned can be in development and/or at post-authorization stage.
Job Responsibilities
* Accountable for ensuring regional (EU) contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects.
* Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post filing activities.
* Partners with project teams and other customer groups (e.g. RU/BU, Regional Commercial Teams) to ensure required regulatory contributions (line plans, label, CTA, MAA/IRD, variations, license renewals etc) meet business needs and are provided to the project teams, to agreed time and quality standards.
* Ensures regulatory plans are monitored, progress/variance communicated to GRL and Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated
* Ensures an aligned regional regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions promoting the regional business are championed and communicated.
* Engages in appropriate activities in order to influence the regional regulatory environment through WRS-In Country colleagues, Agency contacts and/or Trade Associations as appropriate.
* Ensures business compliance and implementation of and adherence to Regulatory standards.
* Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region.
HERE IS WHAT YOU NEED:
Qualifications
* Scientific Degree. A higher degree may be an advantage but is not essential.
* Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process particularly clinical trials experience at least in one country.
* Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable. Equivalent experience, either at a regulatory agency or working on substantive industry-government collaborations, can be considered
* Experience in communicating with major EU regulatory agency(ies), as well as participating in/leading such interactions, is preferred.
Technical Skills
* Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
* Proven ability in developing and implementing regulatory strategy - Familiarity with regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations.
* Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
* Presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior managers.
* Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups. Canbe direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations.
ORGANISATIONAL RELATIONSHIPS:
* Reports to relevant GRPL
* Works with GRS colleagues and relevant project team(s) members (i.e. Clinical and Project Management,
* Development Operations, Global Regulatory Sciences, Worldwide Risk Management, Worldwide Safety Sciences, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal).
* Partners with regional colleagues, including GRS-in Country colleagues, Medical and Commercial colleagues, to provide a regional position.
* Works directly or indirectly with external contacts in Regulatory Agencies within assigned region, as well as relevant experts and key opinion leaders.
* Ensures alignment with GRL and GRPL.
Work Location Assignment: Hybrid
Purpose
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.
Flexibility
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.
DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Regulatory Affairs
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
Pharmaceutical Manufacturing
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