Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Senior Manager - Regional Regulatory
Role Description
• To apply knowledge and interpretation of regulatory requirements of Asian countries to the drug development process with the aim of simultaneous global development
• Single point of contact for WSR Innovative PCO for the designated therapeutic area(s) (TA)
• Single point of regional regulatory contact and strategic partner for Pfizer Innovative Health (PIH) regional organization including but not limited to Regional TA Lead (RTAL) and Medical for the assigned TA
• To manage projects and provide the liaison for headquarter (HQ) regulatory and GCMC strategist, PCOs and relevant supporting functions on registration strategies
• To ensure that regulatory documentation meet relevant regulatory requirements.
• To build local and regional relationships and ensure communication/clarity of regulatory timelines and strategy
Responsibilities
• Regional regulatory strategy and alignment
- Lead the discussion of regulatory strategies and provide input to the WSR regulatory strategy (global, regional, country) for the development of products in line with the PIH business objectives. In conjunction with the PCO, ensure strategies are adequately reflected in the country and regional plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business/commercial plans
- Accountable for bringing regulatory strategy in regional PIH strategic planning process; ensure regional cross functional teams are kept up-to-date regulatory strategies of major NDA and LE applications, and relevant regulatory intelligence
• Knowledge and requirement management
- Ensure product strategies, submission and approval time lines, and country registration requirements/guidelines including dossier build template (DBT) are accurately captured and maintained in applicable systems/regulatory databases
• Registration planning and execution
- Oversee and coordinate as necessary the preparation, submission and review process to ensure that above- and in-country strategists are aligned effectively
- Manage customization and dispatch dossiers to PCOs in conjunction with the PS, GCMC product principle and Hub Submission Manager (HSM) according to internal policy and procedure
- Coordinate with WSR Product Strategist the receipt, distribution and response to regulatory queries from target countries, in line with product role in WSR, consistent with departmental procedures and including liaison with Rapid Response Team members to ensure that response targets are met
- Regularly follow up with PCOs on progress of registration submission and approval activities, and ensure line management is advised of progress in regulatory filings.
- Responsible for notifying WSR above-country strategist and relevant stakeholders about regulatory milestones and changes.
• Regulatory policy and influencing external environment
- Contribute to Regulatory Policy by advising environment and policy trending in the region and coordinate Pfizer comments to draft regulations/guides and communicate new regulatory requirements to stakeholders; provide expertise comment and interpretation where applicable
- Facilitate preparation meetings with WSR above-country strategist(s) for meeting with regulatory authorities, including preparation of background materials, logistical organization and guidance of technical specialists representing Pfizer – all in collaboration with PCO
- Influence the development of regulatory requirements, including development of relationships with external country or regulatory experts and participation, on behalf of Pfizer or Industry group in external conferences
• Maybe assigned as regional regulatory consultant of designated group of countries for other regional and global strategists providing in-depth country knowledge where appropriate
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Project Management :
• Facilitate improvement projects of WSR Innovative International departmental processes and procedures, training curriculum, WSR systems and applicable Pfizer policies and procedures.
• Lead specific regional projects
• Lead cross-functional team to support PCO in capability building and audit readiness
• Provide strategic input and support the authoring of country- or region-specific Early Development Strategy Document (EDSD) when required
• Lead or participate in cross-functional project teams, to address business needs in line with WSR Innovative business units, Medical Departments, and County business objectives.
• Research to clarify, coordinate where appropriate, issues encountered by PCOs to ensure clear and smooth operations that are compliant with internal SOP and standards.
People Management, where applicable:
• Manage the performance of direct report(s) to achieve agreed objectives and to identify and address training and developments needs
• Nurture Pfizer’s OWNIT culture
• Mentor and/or coach other regional strategist in managing complex projects
Qualifications
• Scientific degree
• Appropriate Regulatory Affairs experience - minimum 6 years
• Strategically minded
• Project management skills
• History of delivery – country and/or regional
• Fluent in English – written and spoken communication skills
Additional Information:
Experience : Min 6 years
Qualification : Scientific degree
Location : Multiple Locations
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : Regulatory
Last date : 20th September, 2016
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