Regulatory Affairs Pharmacist at Pfizer

Summary: The country-based Regulatory Affairs Pharmacist (RAP) will provide regulatory support for the Pfizer Biopharmaceutical Group portfolio including registration, pre-approval and post-approval activities. The country-based RAP supports and reports to the Country Head of Regulatory Affairs (HRA). The country-based RAP supports the Country HRA with the development and execution of regulatory strategies and plans for the country. The country-based RAP will support broader country/hub projects as required by the HRA.

Job Responsibilities:
Compile and submit new product applications, clinical trial applications, generic applications, new indications or line extension applications to the relevant HA’s/BoH’s, ensuring that local registration requirements are fulfilled.

• Conducts document review to ensure the regulatory quality and scientific integrity of documents submitted to HAs.
• Liaise with clinical research project managers to seek to understand clinical research programmes.
• Ensure timely communication of any GCP breaches, or actions taken for safety reasons.
• Support the local RA team, local clinical operations or third party vendors and regional AfME organization in the execution and implementation of country-specific regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management.
• Develop and maintain strong partnerships with in-country (e.g. BU leads, H&V, Marketing, Supply Chain, Medical) and with above country (e.g. RRLs, product RA Strategists, GRLs, Submission, Maintenance and labeling/artwork Hubs,) to effectively execute registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
• Responsible for their own personal development and performance to achieve company objectives and agree training and development needs with Country/Cluster Regulatory Heads to develop and enhance individual capabilities and capacities.
• Responsible for developing and enhancing relationships with key external agencies (i.e. HA’s/BoH’s). Manage the HA/BoH interface throughout the development and lifecycle of a product.
• Support the Country/Cluster HRA in local trade association activities as required.
• Understand local regulations and developing trends in the local regulatory environment. Leverage regulatory intelligence / landscape knowledge to anticipate barriers and recommend alternative approaches in line with local policies and procedures.
• Responsible for the co-ordination of regulatory activities associated with product approval, including the development and submission of responses to HA queries and requests, and monitoring and following-up on progress of regulatory submissions at the HA.
• Maintain licenses (e.g. Marketing Authorizations) relating to all dossier maintenance activities (amendments, label updates etc) in compliance with local regulations, corporate regulatory processes, SOP’s and systems.
• Where needed, oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established RA performance metrics.
• Maintain compliance of local product artwork in line with local legislation, regulations and Pfizer standards through the undertaking of thorough reviews of these documents as outlined in local Work Instructions (WIs).
• Serve as a Deputy Responsible Pharmacist or delegated Responsible Pharmacist in the absence of the permanent appointed Responsible Pharmacist.
• Sign on regulatory dossiers as the pharmacist responsible for the application.
   

Qualifications:
Experience:

• Bachelor’s degree in Pharmacy or Diploma in Pharmacy
• Experience in regulatory affairs, preferably in human medicines - minimum of 3 years’ of experience in RA.
• Demonstrable relevant experience across the product development, commercialization and maintenance lifecycle, with proven examples of contribution.
• Proven ability to manage complex regulatory issues.
• Proven ability to consistently deliver to time, cost and quality standards.
• Regional/Country regulatory experience including submission processes and product life cycle management activities.