Manager, Regional Regulatory Hub StrategistWe're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated colleagues like you who are experts in their field and can keep their well-being as their topmost priority.
What You Will AchieveYou will represent Pfizer as a manager in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.
As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
It is your dedication and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve ItApply regulatory expertise for assigned therapeutic categories/countries to enable preparation of high quality documentation and assure compliance with departmental procedures.
Provide input to the Global/Regional regulatory strategy team for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business/commercial plans.
Liaise with relevant partnerlines from PRD/GRS-EM, GCMC, PGS, Submissions Management, CRS, 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.
Support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
Manage regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
Co-ordinate with Global/Regional Strategist the receipt, distribution and response to regulatory queries from target countries, consistent with departmental procedures and including liaison with RRT members to ensure that response targets are met.
Manage customization and dispatch dossiers to CRS.
Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure that Global/Regional partnerlines are aware of regulatory requirements (e.g., department presentations and Regulatory Requirements database) and assist EM Policy with assessing the regulatory environment and identifying relevant trends.
Regularly follow up with CRS on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.
Project Management
Ensure product strategies, submission and approval timelines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
Participate and/or lead cross-functional project teams, to address business needs in line with PBG EM business units (including but not limited to Medical, Commercial and PGS business objectives).
Support assigned countries at relevant regulatory and project teams, or inter-divisional meetings, as appropriate.
Ensure that comprehensive records of communications, country requirements and regulatory status are maintained.
Support filing and approval goals for the region.
To regularly follow up progress on regulatory submissions with CRS countries.
Special Task
Lead and be the SME/Point of Contact for Projects/Systems/Processes within the GRS IRSP Asia Regional Regulatory Hub.
May be assigned to manage Contractors/Interns or relevant staff for assigned projects.
Policy shaping initiatives relevant to TA or in-support of PCO.
QualificationsScientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential.
Appropriate Regulatory Experience – minimum 3-6 years experience (Job Grade specific).
Proven ability to manage complex regulatory or drug development issues.
Proven ability to consistently deliver to time, cost and quality standards.
Fluent in English – written and spoken communication skills.
Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred.
Proven performance track record - country and/or regional.
Country/regional knowledge.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.#J-18808-Ljbffr