Use Your Power for Purpose
We are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will play a pivotal role in broadening and hastening patient access to Pfizer's medicines and vaccines.
What You Will Achieve
JOB SUMMARY:
- Single point of contact (SPOC) representing regulatory at regional level for the identified region and Therapeutic Area (TA) products to facilitate the best-in-class support for new product registration and lifecycle management activities.
- Collaborate and engage with multiple partner lines across Pfizer including Global Regulatory Strategists (GRL, EM RS, CMC PS), Country Regulatory Strategists (CRS), Regulatory Operations, Clinical, Commercial, Medical and Supply Chain to align on priorities and strategies to effectively deliver regulatory submissions in line with business and supply plans.
- Apply knowledge and best interpretation of regulatory requirements to ensure the regulatory dossiers of assigned product(s) contain appropriate data/information based on Board of Health (BoH) regulatory expectations and are clearly written to effectively express Pfizer’s scientific position.
- Execute high quality communications with both external BoH and internal stakeholders to articulate understanding of regulatory strategies, timelines and associated complexities.
- Provide timely and decisive regulatory advice to enable stakeholders to make well-informed decisions on product development, lifecycle planning, business development and supply planning.
- Ensure adherence to regulatory processes and systems per assigned responsibility identified in internal SOPs and policies.
JOB RESPONSIBILITIES:
Regulatory Strategy and Expertise:
- Lead the development and implementation of regional regulatory strategies for assigned product(s) that are in-line with business objectives, ensuring regulatory 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/supply plans.
- Liaise with various Regulatory partnerlines including Global Regulatory Lead (GRL)/EM Regulatory Strategists (EM RS), GCMC product strategists (CMC PS), Submissions Management (iGSM, HSM), Labelling (HLM), Artwork (ALIM), Country Regulatory Strategists (CRS) and any other key cross-functional stakeholders such as PGS Sites including participation in relevant planning/kick-off meetings, to ensure a submissions-ready dossier that meets both external BoH requirements and internal timelines as aligned cross-functionally.
- Coordinate with CRS and Global Regulatory Strategists on the receipt, distribution and response to BoH queries in a compliant manner with internal procedures, including liaising with Rapid Response Team members as necessary to ensure that response targets are met.
- Aid CRS in preparation and conduct of interactions with BoH as appropriate.
- Conduct regular checks with CRS on progress of registration activities and timelines, including ensuring the appropriate planning and forecasting tools are utilized to update regulatory timelines promptly to facilitate downstream stakeholder planning. Provide effective and timely communication to line management and stakeholders on key progress in regulatory filings, including actual submission and approval notifications.
- Support GRS Policy and CRS with assessment of country regulatory environment and identifying relevant trends.
- Proactively anticipate impact from potential regulatory issues and propose innovative solutions to meet business objectives, while maintaining compliance with BoH regulations and internal quality systems.
Project Management
- Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries, and ensure that Global Regulatory Strategists are aware of new or revised regulatory requirements through timely update of Regulatory Requirements Database and presenting at awareness sessions as necessary.
- Represent or support assigned countries at relevant regulatory project teams or cross-functional meetings.
- Ensure maintenance of department regulatory intelligence materials such as EM RRHS Training Playbook and Country Intelligence decks.
QUALIFICATIONS / SKILLS:
- Bachelor’s degree or equivalent in Pharmacy, Biological Sciences, Chemistry or health-related discipline. Advanced degree (MSc, MBA, PhD etc.) may be an advantage.
- At least 3 years of appropriate regulatory/work experience.
- Demonstrable country/regional knowledge and experience of regulations/guidelines as well as regulatory processes for Pharmaceutical Growth and Lifecycle Management.
- Ability to manage complex problems/projects by exercising strategic analysis, innovative thinking and high degree of flexibility to adapt to changes in regulatory environment and business situations.
- Collaborative skills to thrive in a multi-cultural and matrix work environment
- Good performance track record with proven ability to consistently deliver to time, cost and quality standards.
- Strong written, spoken and presentation communication skills in English
- Attitude: Growth mindset, Change agile, Team player, Innovative thinking, Strategically minded, Project Management skills preferred, seeks Process Improvement.
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Regulatory Affairs