PLMDS-RDCM Centre of Enablement, Manager

Use Your Power for Purpose
We are committed to bringing medicines to the world at a faster pace 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 dedication and expertise are vital in expanding and accelerating patient access to Pfizer's medicines and vaccines.
What You Will Achieve
In this role, you will:
Lead and manage the regulatory data quality and conformance across systems and markets and support the global regulatory operations and compliance. The role requires you to drive innovation and efficiency, influence business decisions and strategies related to regulatory data and work to establish best practices that can be centralised and de-centralised across RDCM. Through driving and enablement of process updates you will support to coach and guide RDCM as needed. Some of the key responsibilities include

• Managing and improving the quality and accuracy of regulatory data and milestones across all regulatory systems used for conformance, data management and communication activities.
• Collaborate and lead either directly or through matrix oversight, a diverse and global team of data professionals and ensuring effective communication and collaboration with stakeholders, such as GRO, CMC, LOCs, and external partners.
• Driving innovation and digital transformation in data management processes and systems, and leveraging data analytics and insights to support business objectives and performance
• Influencing senior management decisions and business strategies related to regulatory data, and providing data-driven recommendations and solutions
• To ensure accuracy and timeliness of relevant data entry into the appropriate systems in accordance with regulatory and internal standards
• To act as a subject matter expect and a mentor for the work team and share knowledge and expertise on relevant systems including regulatory requirements where applicable.
• Working with GRO stakeholders to coordinate and deliver regulatory compliance activities across the portfolio on time, such as SCC and PEARL projects, submissions, updates, and audits

Here Is What You Need (Minimum Requirements)
Type of Experience

• Preferred years of experience: minimum 7 years of experience in a quality or compliance role within the pharmaceutical industry
• Is a qualified and experienced professional in the pharmaceutical industry, with a focus on quality and compliance.
• Has experience and knowledge in regulatory and quality assurance aspects of life cycle management and compliance

Preferred Qualification

• Master's / Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.

Technical Skills

• Computer literacy in Microsoft 365/ Teams/Adobe Acrobat. Experience with publishing software, XML, Document Management, regulatory milestone reporting tools
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
• Has intermediate to advanced English skills, both written and spoken Standards, Processes and Policies
• Understands the technical and regulatory requirements for drug development and approval in various markets and able to interpret the impact on local processes.
• Knows and follows the standards, processes, policies, rules, regulations and guidelines for pharmaceutical manufacturing

Bonus Points If You Have (Preferred Requirements)

• Master's degree with relevant pharmaceutical experience
• Ability to work cross-functionally on broad and strategic initiatives
• Strong leadership and team management skills
• Excellent communication and interpersonal skills
• High attention to detail and organizational skills

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 Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Pursuant to Article 24(6) of the Act of June 24, 2024 on the protection of whistleblowers, Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure, which, in accordance with the provisions of the aforementioned Act, is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address [email protected].
Regulatory Affairs