Pfizer China RA Head in Beijing, China
Role Summary: The position has overall regulatory responsibility for the development of new products in the portfolio and marketed products for IMBin China in order to obtain timely approvals with competitive labeling,to ensure optimal regulatory compliance, and to optimize planning and execution of regulatory strategy for the entire productlife cycle. Responsible for building and maintaining excellent relationships with regulatory agencies to influence the regulatory system in China; proactively working with industry associations to plan and implement regulatory advocacy strategies Accountable for all direct contacts and interactions with national Regulatory Authorities through local RA representatives. Responsible for alignment of the Regulatory colleagues in China strategically and operationally to support the objectives of the China business. Responsible for creation and maintenance of a strong network through participation in and where appropriate leadership of local RA organizations and local industry associations. Responsible for implementing GRA's transparent one-voice policy and maintaining close alignment with other PFE stakeholders including commercial, medical development, regulatory operations, PGS, CMC, and safety.
Organizational Relationships: Reports to Head of GRA International
Resources Managed (budget and FTEs): The role manages a team of 40+ FTEs with people manager direct reports.
- Serves as a key member of the extended Development China (DC) leadership team
Demonstrating extensive China regulatory knowledge & experience, balanced judgment, crisp decision-making and exemplary collaboration & business acumen
Responsible for regulatory strategy decisions on new Product Registration & in-line products maintenance for IMB as a basis for business decisions.
Ensures effective communication between the GRA global lines and teams and the China RA org, as well as between DC and the local RA organization.
Ensures the achievement of China business goals by implementation of timely and high-quality CTA and NDA/IDL submissions and by obtaining on-time marketing authorizations (including major variations and labeling changes).
Ensures timely RA supports to new business growth drivers
Ensures aligned communication across different BUs
Ensure development of strategies that leverage regional collaborations in Asia working with the GRA Internal - Asia group, DC, DJ, and other stakeholders
Enhancing Working Relationship with Health Authority
Exercising & enhancing engagements / relationships with regulatory authorities to improve Pfizer 's regulatory success and may serve externally as a representative to pharmaceutical trade group advisory committees. E.g. Member of RDPAC
Interfaces with NMPA/CDE/other relevant authorities to optimally position Pfizer as a key strategic partner in China.
Anticipates, communicates, and influences changes in regulations, guidelines, and policies that may affect the approval of new drugs or current marketed drugs in China, working with the global regulatory policy and intelligence group in GRA and other stakeholders.
Works with other stakeholders to ensure regulatory compliance in China according to local regulatory requirements and internal PFE standards.
Talent development and team construction
Develops and maintains motivated and competent RA staff in China through participation in hiring, training, development and advancement. Instills and maintains a culture of innovation and transparency throughout the China RA organization.
Technical / Behavioral Competencies: Technical
Recognized expert with leading-edge knowledge of the drug development process and laws, regulations and practices affecting the pharmaceutical industry
Extensive relevant regulatory experience & business knowledge. Well connected to the external regulatory & pharmaceutical environment.
Strong management and project leadership skills, ability to provide advice and counsel to company staff for strategic decisions; routinely consulted as an internal expert on regulatory strategy. Serves as an external expert on regulatory policy.
Able to Influence and drive HQ decisions on China related projects.Demonstrates ability to apply regulatory knowledge to guide labeling recommendations and design as well as implementation of clinical development programs
Ability to organize/coordinate successful HA meetings/ manage complex relationships, working to effectively negotiate product approval and in-line product defense
Strong leadership - Creates & develops new strategic paradigms, directions & policies within the regulatory functions & division. Recognized as an outstanding regulatory leader & scientific/technical strategist across the division.
Good understanding of the international and Chinese regulations and guidance in order to design and implement robust strategies for new product registrations in China,
Excellent skills in communication, collaboration, negotiation and problem solving
Excellent English both spoken and written
Sustain Focus on Performance
Encourage Open Discussion and Debate
Align Across Pfizer
Qualifications (Training, Education & Prior Experience): Certifications
A bachelor's degree major in biology, chemistry, pharmaceutics, medical or a related life-science discipline, or equivalent. A master's degree or above is preferable.
At least 15 years' experience in multinational pharmaceutical companies including at least 6 years as a team leader. Registration experience across small molecules, biologicals, and vaccines preferable.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.