We have anexcitingopportunityforaRegulatoryStrategist(Manager)tojoinour VaccinesGlobalRegulatoryScience team. This is an excellent opportunity tojoinagrowing anddynamicteamandbeincharge ofvariousprojectsacrossdifferentfranchises. We are looking for candidates with a dynamic and agile profile with a scientific background,andregulatoryexperience. The candidateshouldbepassionatefor vaccines, willing to learn and advance in their career.
Responsibilities:
Reports to the Global Regulatory Lead:
1. Assist in developing and implementing regulatory strategy that aligns with business needs, including growth projects and activities relating to maintaining registrations, product defense and regulatory compliance
2. Contribute to regulatory strategy and operational activities for projects/products (including across different franchises within Department): preparation and submission of correspondence and applications to regulatory agencies.
3. Participate in Regulatory and cross functional teams for assigned projects/products. With appropriate supervision, direct and/or indirect liaison with Health Authorities (in conjunction with Country Regulatory Leads (CRLs)) to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures
4. Implementing systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring the sharing of information and learnings across the relevant lines.
5. Plays a supporting role in any appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.
Qualifications:
6. Bachelor degree in a science subject together with appropriate pharmaceutical industry experience gained within a global regulatory affairs function.
7. Strong proven experience
8. Understanding of vaccines and immunology advantageous.
9. Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation and awareness of the functioning of the pharmaceutical industry
10. 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
11. Strong problem solving skills
12. Strong written and verbal communication skills
13. Ability to work well with appropriate level of independence and appropriate level of supervision
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 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.
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