Manage projects and regulatory strategies for allocated products, and ensure communication/clarity of regulatory timelines and strategy.
Single point of contact for global/product strategists, and In-Country Regulatory Team on regional issues to facilitate the best in class support for product registration and product life cycle management activities.
Responsible for ensuring that regulatory documentation meets relevant regulatory requirements.
Apply knowledge and best interpretation of regulatory requirements in the assigned countries to the drug development process, including promulgation of health authority marketing authorization dossiers to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.
Ensure business continuity between global/product strategists and In-Country Regulatory Team.JOB RESPONSIBILITIES
Maintain knowledge base of country requirements and regulatory environment.Maintain effective regional relationship with stakeholders to ensure communication /clarity of regulatory strategy and timelines.
Apply regulatory expertise for assigned products/countries to enable preparation of high quality documentation and assure compliance with departmental procedures.
Provide regional input to global regulatory strategy for the development of products in-line with business objectives, Assist and liaise with global/product strategists, PGS, Submissions Management, In-Country Regulatory , ILG, ALIM, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
Assist and support all product lifecycle regulatory work, and liaise with CMC strategists, Submissions Management, Cluster/Market, and any other key stakeholders.
Assist and oversee the preparation of regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
Dispatch dossiers to In-Country Regulatory .
Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure that global/product strategists are aware of regulatory requirements (e.g., department presentations and Regulatory Requirements Database) Regularly follow up with In-Country Regulatory Team on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.
Maintain Pfizer systems and databases, and applicable Pfizer policies and procedures.
Responsible for ensuring product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
Responsible for ensuring notifications of proposed regulatory changes are communicated to relevant stakeholders in a timely manner.
Participate on functional project teams in line with business needs. Responsible for ensuring that comprehensive records of country requirements (communication of requirements for RRM updates) and regulatory status, are maintained.
Regularly follow up progress on regulatory submissions with In-Country Regulatory.
Contributes to the development of filing and approval goals for the region.
Ensure systems are in place and adhered to, to optimize process efficiency with out-sourced and in-house contractors, where applicable.QUALIFICATIONS / SKILLS
Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential.
GRRSPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.