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:
- Bachelor’s degree in Pharmacy or Diploma in Pharmacy
Experience:
- 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.
Attributes:
Understanding stakeholder needs
Understanding internal and external stakeholder needs to gain trust, settling differences and winning concessions without damaging relationships.
Network and alliance building/ peer relationships
Uses an informal system of external and internal contacts to facilitate and share ideas and learning. Establishes and maintains a wide range of relationships to support, guide and enable improved personal and organizational performance. Can quickly find common ground and solve problems for the good of all. Is seen as a team player and is cooperative.
Influencing
Uses a range of communication styles and choosing appropriate strategies to deliver goals against a backdrop of diverse agendas, priorities and cultures.
Team working
Able to work with individuals and comfortable acting in a wide range of team roles in the wider project interest.
Interpersonal acumen
Relates well to all levels of people inside and outside the organization. Build constructive and effective relationships, uses diplomacy and tact and can diffuse high-tension situations comfortably.
Perspective
Looks toward the broadest possible view of issues/challenges and is able to project impacts to the future.
Strong quality and compliance orientation
Has an understanding of regulatory compliance issues and the potential impact of compliance related issues on meeting business objectives.
Analytical thinking
Can analyze large quantities of complex scientific data and synthesize this with external regulatory environmental trends into workable regulatory strategies and issue mitigation.
Adaptability
Able to build effective working relationships and deliver results in wide range of environments and cultures.
Skills:
Knowledge of the regulatory environment and how this impacts regulatory strategy and implementation
Understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment. In depth knowledge of regulatory requirements and local regulations. Experience in preparing and submitting new product applications (new, generic, line extension), clinical trial applications and variations. Working with PCO’s and
HAs in facilitating approval of submissions. Is driven to continually enhance regulatory expertise.
Knowledge of local legislation, regulations and guidelines
Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to regulatory strategies and implementation plans such as Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
Strategic thinker
Provides strategic contribution, problem solving and anticipates what RA needs to contribute to develop and achieve business objectives. Effectively explores alternative regulatory strategies and positions to reach outcomes that gain the support and acceptance of all parties.
Communication skills
Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message. Demonstrates strong writing skills and computer literacy. Demonstrates good interpretive skills.
Negotiation skills
Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust of other parties to the negotiations quickly. Has built a strong relationship with the local health agency and other relevant stakeholders and pro-actively manages issues with the HA’s and other key external stakeholders.
Problem solving
Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed upon solutions.
Detail orientated
Meticulous, accurate and a high level of attention to detail:can be thorough and complete tasks with high quality standards.
Project management
Can manage complex and multiple projects through a planned and organized approach, using good planning, organisational and analytical skills. Able to multi-task, work under pressure and meet deadlines.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
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