Regulatory Data Coordinator, Manager

Pfizer; Maidstone; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A global biopharmaceutical leader in Maidstone is seeking a Regulatory Affairs professional to manage RIM events, ensure compliance with data governance, and support cross-functional collaboration. The ideal candidate will hold a Bachelor's or Master's degree in Life Sciences and have experience in regulatory operations. This role requires strong communication skills and attention to detail, as well as the ability to navigate complex regulatory environments. Join us to make a difference in patients' lives.

Benefits

Flexible workplace culture

Diversity and inclusion initiatives

Qualifications

• Experience in regulatory operations and change management.
• Detailed understanding of regulatory systems and compliance needs.
• Proven ability to manage product and registration information.

Responsibilities

• Manage RIM events and ensure accurate reflection of product market registration.
• Evaluate and approve data change requests for compliance.
• Facilitate delivery and approval of regulatory submissions.

Skills

Regulatory Affairs experience

Data governance principles

Attention to detail

Collaboration skills

Technical aptitude

Education

Bachelor's or Master's degree in Life Sciences

Job description

JOB RESPONSIBILITIES

Management of all related RIM events and their related records, including event details and registered details – ensuring structures and relationships enable accurate reflection of the product market registration while still aligning to master data, and ensuring maintenance in alignment with agency decisions.

HA Decision / Interaction management : Interpreting communications and drive appropriate actions to update system (and potentially notify stakeholders even if accountability for that remains with the Reg Strategist), collaborating with Stakeholders across GRS & CMC strategists, PGS, and other teams to understand data requirements and ensure data needs are met.

Review and Approve Data Changes : Evaluate and approve data change requests, ensuring compliance with data governance policies.

Active Dossier Management : Ensuring maintenance across the lifecycle, including in alignment with agency decisions.

Provide Training and Support : Train & support business users on data quality standards and data & process management best practices.

Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum process in support of products through the development and commercial Lifecyle of a drug.

Ensure escalations, business process & solution achieves business needs.

Evolve service based on strategic objectives – efficiency / quality drivers.

Typical Tasks :

Collaboration and Communication : Work closely with business units, IT, and other stakeholders to understand data requirements and support data-related initiatives.

Lead data review / update meetings. Provide guidance and support to system users through an advanced understanding.

Notifications and Reporting : Ensure that notifications are sent to relevant stakeholders upon completion of data updates.Generate reports on data quality, data requests, and other relevant metrics.

Review Event Information : Ensure understanding of the event's purpose and scope. Interpret and understand the change items to ensure appropriate event details are updated to enable proper impact assessments and GPC structure to be created.

Create Event Details : Use the wizard to create event details, selecting appropriate actions and fields.

Run Impact Assessment Report : Generate the report to identify impacted registrations.

Create Related Records : Use the wizard to create activities and other related records based on the impact assessment report. Verify the records created by the wizard and confirm their accuracy. Check for any discrepancies and ensure all data is correctly entered and linked.

Facilitates delivery and approval of Pfizer electronic and paper regulatory submissions through co-ordination and execution of CMC components to unique requirements and standards of each submission and national market.

Through active management of status and expected deliverables, identifies risks and partners with regulatory strategists and relevant stakeholders to mitigate risks to quality and timeliness of CMC changes while ensuring status is accurately reflected at all times through maintenance of metadata in regulatory workflow and / or document management system(s).

Contributes to the completion of moderately complex projects.

Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team.

Applies skills and discipline knowledge to contribute to the achievement of work within Work Team.

Makes decisions to resolve moderately complex problems in standard situations.

Makes decisions within guidelines and policies.

Participates and contributes as a team member.

Provides guidance to and / or may lead / co-lead moderately complex projects.

Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Department.

Applies skills and discipline knowledge to contribute to the achievement of work within Department.

Makes decisions that may require developing new options to resolve moderately complex problems.

Makes decisions guided by policies in non-standard situations.

Regularly takes informal leadership role during Work Team meetings to facilitate agreements and move the Work Team toward its goals.

Acts as a subject matter expert with extensive regulatory, system & process expertise working in close matrix collaboration with strategists and other local and above country cross-functional stakeholders.

Represents the RIO function and plays key roles in RIO, GI&PE and GRS improvement projects.

QUALIFICATIONS / SKILLS

Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field.

Some experience in Regulatory Affairs or Regulatory Operations, with an understanding of data governance, data management, or data quality role.

E2E global regulatory change management experience, including change initiation, performing impact assessments, submission to HA and management of HA decisions / queries / interactions / commitments.

Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs and support compliance.

Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork / Labeling.

Detailed understanding of GRS roles / responsibilities related to dossier maintenance and submissions.

Strong understanding of data governance principles and best practices.

Experience with master data management and data quality improvement.

Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.

Strong communication and collaboration skills.

Attention to detail and commitment to data accuracy and integrity.

Product lead / support experience, including management of product / registration information in systems.

ORGANIZATIONAL RELATIONSHIPS

Regulatory Strategy, CMC leads, Clinical, Non-Clinical, Data Coordinators, RIO, Digital.

Will work in a highly matrixed environment and in close collaboration with Operations and Strategy.

Work Location Assignment : Hybrid (some office presence is required)

Purpose

Breakthroughs that change patients' lives ... At Pfizer we are apatient 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