11 days old

GRA Head, Greater China Region

Pfizer
Beijing
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**Upjohn Global Regulatory Affairs (Upjohn GRA)**



**Job Title:** **GRA Head Greater China**

**Organization** **Upjohn GRA**

**Line (if applicable** **Greater China**

**Department/Group (if applicable)** **Upjohn**

**Region and/or Country (if applicable)** **China**



**Organizational Relationship(s) including to whom the position reports (JD Job Title):**

Direct Report to Upjohn Head of Global Regulatory Affairs (GRA)

Member of Upjohn Global Regulatory Affairs Leadership team

Leader of Regional Regulatory Leadership team including applicable clusters, countries, regional team, and growth/BD lead(s)

Member of the appropriate Regional Commercial Extended Leadership teams

Collaboration with WSR Safety and Regulatory Operations

Collaboration with EMB Regional Manufacturing and Quality



**Position Purpose**



ROLE SUMMARY

The core purpose of this role is to provide and ensure regulatory strategies are in place and implemented for all products in scope (countries) in order to meet Upjohn Business priorities. This requires a detailed understanding of each product, the country and regional regulatory environment for the established markets, as well as the internal global and regional business and priorities. Responsible for regulatory assessment of business development and growth opportunities in the Upjohn Greater China Region. The role is also responsible for ensuring compliant maintenance and conformance for the active on market portfolio. In addition excellent relationships are required with regulatory agencies to both influence current and future regulations and to problem solve specific project/compound /product (and portfolio level) issues. The role covers all phases of the product lifecycle. Ability to manage priorities and set clear direction is important. The role demands clear leadership with excellent communication and stakeholder management.

Leadership, strategic direction and general management of the Upjohn Business Greater China Regional Regulatory Affairs team including relevant country teams and Product Value and External Growth lead

Regional/local contribution to global product regulatory strategies (including labelling) and local implementation (including risk identification/mitigation) to ensure timely delivery and maintenance of products for patients with appropriate labelling.

Deliver Upjohn Greater China Operating Plans (Regional and Country level) in partnership with Upjohn Global Strategy and ensuring priorities are met

Single point of contact for integration of regional/country regulatory activities with key regional/country stakeholders(Medical/Commercial/Legal/PGS/Country Managers/Safety/GCMC/RegOps)

Ensure consistent quality and standards of regulatory and management processes and deliverables to ensure full compliance with all regulations and corporate policies in collaboration with other Upjohn Global and Regional Regulatory teams. Accountable for regulatory remediation project and activities within the Region.

Ensure excellent working relationships/partnership to consistent quality and standards with all in scope Regulatory Agencies

Contribute to regulatory policy at regional/local level (both environment understanding and influencing) ensuring global corporate alignment in collaboration with the global regulatory and intelligence function in WSR and Upjohn Global Regulatory Affairs

Accountable for capacity and capability management across Region

Enable professional development of staff through talent management across and between regions

Share best practices and strive for simplification and continuous improvement of all processes



**Primary Responsibilities**



ROLE RESPONSIBILITIES

To provide and ensure regulatory strategies are in place and implemented for all products in the Upjohn portfolio in order to meet Commercial Business Unit priorities.

Establish and lead the Upjohn Greater China Regulatory Affairs Leadership Team. Establish a process for developing team objectives that are in alignment with the Upjohn R&D global, regional and local country objectives, as well as externally with other key stakeholders (Commercial, PGS).

Ensure country regulatory leaders develop and maintain excellent relationships with regulatory agencies to both influence future regulations and to problem solve specific project/compound/product issues. Partner with corporate affairs, government affairs, and others local policy leaders to achieve business policy objectives.

Provide leadership, strategic direction and general management of the designated Upjohn Greater China Regulatory Country Organization ensuring consistent performance and talent management as well as delivery to time, cost and quality.

Ensure coordination and implementation of consistent standards and process throughout the country regulatory teams, and to establish alignment with regulatory processes/principles and corporate leadership priorities and values.

Establish and implement strong partnerships with in-country and regional stakeholders (e.g. Country Managers, Medical Affairs, Marketing, PGS) to foster the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization, as well as business development opportunities.

Establish/define the role and required competencies of the in-country RA Leads, and oversee the development and implementation of strategies to enhance the capacity and capabilities of the Greater China RA team. Direct/provide opportunities including training/rotational development, professional growth and development of the country based RA teams.

Develop and oversee the implementation of processes to facilitate a regional opportunity assessment of development candidates, and to ensure that processes and systems are in place to effectively capture country/regional input to global registration strategies.

Collaborate with the WSR Regulatory Policy and Intelligence teams and Country/Regional Strategists to ensure that processes are in place to monitor and positively influence the local/regional regulatory environment as relevant to the Upjohn Business. Establish procedures and processes to ensure that knowledge gained through this process is captured (e.g. best practices, requirements databases, etc.) and incorporated into ongoing and future regulatory strategies.

Work closely with the in-country regulatory staff to develop and strengthen HA relationships and ensure the delivery of a single One Pfizer voice.

Collaborate with Upjohn Regulatory Product Strategists, PCOs and Regional Clinical Development/Medical Affairs and Commercial to develop HA and KOL interaction strategies that are in alignment with filing strategies.

Contribute to change management and continuous improvement projects.



**Technical Skill Requirements**

Regulatory experience (1) with marketed drugs, Advisory Committee and other Health Agency Hearings

Network and alliance building/peer relationships Able to interact with a variety of disciplines to establish policy and optimize processes

Strong Logical and analytical skills- Uses Rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at first answers

Communication skills Able to communicate complex information and analysis to a variety of scientific and non-scientific audiences

Regulatory Infrastructure (2) Understanding of and experience with the processes and interactions essential for maintaining strong and comprehensive regulatory representation on project and product teams

Line Management/Supervision (3) Able to mentor less experienced staff to represent the full knowledge and experience base of WSR in their team interactions; Clearly Assigns responsibility for tasks and decisions, sets clear objectives and measures, monitors process, progress and results; Strong and proven abilities in Line management with excellent teaching and coaching skills



**Qualifications (i.e., preferred education, experience, attributes)**



BASIC QUALIFICATIONS

Demonstrable experience across the drug development and commercialization lifecycle, with proven examples of contribution. Experience with established products and generic drug regulatory submissions and approvals.

Proven ability to manage complex regulatory issues.

Proven ability to consistently deliver to time, cost and quality standards.

Regional regulatory experience including knowledge of clinical trial and marketing application submission processes and product life cycle management activities.

General management experience and previous line management and leadership experience at senior management level is essential.

Demonstrable experience of effective delivery in a complex matrix environment.

Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation.

Knowledge of drug development practice, rules, regulations and guidelines.

Scientific degree

Appropriate Regulatory Experience to fulfill this leadership role - minimum 10 years experience



PREFERRED QUALIFICATIONS

A higher degree (MS or PhD) may be an advantage but is not essential.

Management Degree (Diploma or MBA) may be an advantage but is not essential.

Pharmacist degree may be mandatory in some countries.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Regulatory Affairs
Posted: 2020-10-13 Expires: 2020-11-13
Sponsored by:
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GRA Head, Greater China Region

Pfizer
Beijing

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