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 Pfizers 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

• Masters / Bachelors 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)

• Masters 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

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