JOB INFORMATION

• Lead, manage and provide strategic direction to the cluster/country regulatory team.
• Accountable for all strategic regulatory activities for the cluster/country including pre- and post-authorization product lifecycle activities and delivery of operational regulatory activities in partnership with above-country operational hubs.
• Deliver cluster/country strategic priorities and operational plans to budget and support delivery of regional regulatory objectives. Provide regulatory guidance/input into global and regional product development regulatory strategies.
• Accountable for effective relationships with the local Regulatory Authority and representing the company at the regulatory committee(s) of the national Trade Association(s).
• Oversee and manage the completion of CTA (if is applicable).

JOB RESPONSIBILITIES

Leadership and Strategic Role

• Lead and manage the cluster/country team in the development of regulatory strategies for registration of new products and line extensions, post approval variations and their lifecycle management.
• Ensure that the team provides input into global and regional development and regulatory strategies to provide optimal support for meeting regional and cluster/country business objectives.
• Responsible for the leadership, development, and performance management of the cluster/country team to achieve company objectives and culture. Develop and enhance the capabilities and capacities of the team through the identification and implementation of training and development needs.
• Ensures that all regulatory activities in the cluster/country are managed in compliance with Pfizer standards and international/local regulations.
• Effective communication to stakeholders of key issues that could impact regulatory strategies or the business.

Operational Excellence

• Ensure internal regulatory processes and procedures are followed according to Pfizer policies and procedures and support compliant regulatory activities.
• Understand local regulations and developing trends. Leverage regulatory intelligence/landscape knowledge to support the development and implementation of regulatory and business strategies, and decision making.
• Influence new legislation initiatives that could impact the business.
• Assure local licenses in country(ies) under responsibility are maintained (e.g. Marketing Authorizations) incompliance with local regulations and following corporate policies, regulatory processes and SOPs (e.g. CMC change control, product labelling, single channel of communication, etc.)
• Active participation in the trade organization and serves as the Pfizer representative at industry.

Clinical Trials

• Oversight of local Regulatory Authority submissions and approvals for Pfizer sponsored Clinical Trials and the maintenance of approved CTAs in country(ies) under responsibility.
• Ensure Cluster/Country Regulatory Strategy accountabilities are fulfilled as defined in Alliance Partner Task
• Ownership Matrix.

Technical Director’s responsibilities

QUALIFICATIONS

• Scientific Degree – such as life sciences or chemistry. Pharmacist degree may be mandatory in some countries.
• A higher degree (MSc, MBA or PhD) may be an advantage but is not essential.
• Extensive experience in regulatory affairs - minimum 10 years, preferably in human medicines.
• Demonstrable knowledge across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
• Proven ability to manage complex regulatory issues.
• Proven ability to consistently deliver to time, cost and quality standards.
• General management experience and previous line management and leadership experience at senior management level is essential.
• Regional regulatory experience including knowledge of NCEs and Biological products submission processes, CTAs applications (as applicable) and product life cycle management activities.
• Demonstrable experience of effective delivery in a complex matrix environment.

SKILLS

• Strong leadership qualities and management skills, including talent development, team working, problem solving, communication and interpersonal skills.
• In depth knowledge of national/regional regulatory legislation and guidelines. Understanding of business and financial environment, drug development process, local healthcare system and the pharmaceutical industry.
• Knowledge and understanding of quality systems, processes, audit and inspections.
• Ability to influence at all levels in the organization and build networks internal and externally.

ORGANIZATIONAL RELATIONSHIPS

Internal Partnerships

• Develop strong partnerships within the cluster/country (e.g. Country Managers, Medical, Marketing, Supply, Quality), and above-country functions (e.g. GCMC, GRS Regulatory Hubs, Regulatory Operations) and above-country GRS Therapeutic Area and Regional Teams to facilitate the development and implementation of regulatory strategies to expedite the registration of new products, line extensions and life-cycle optimization.
• Provide strategic contribution to the country (PCO) or cluster markets that support leadership team – anticipate what Regulatory needs to contribute to achieve business objectives, e.g. BU Strategic and Operating plans.
• Collaborate with EMB GRS and Consumer Health Regulatory cluster/country leads to align on regulatory positions on pan-portfolio or policy topics for communication to in-country internal and external stakeholders.

External Relationships

• Responsible for developing and enhancing relationships with key external entities (HA’s/BoH, RKOL’s, etc.).
• Manage the HA/BoH interface throughout the product development and product lifecycle, developing a long term and positive relationship characterized by Integrity, Quality, Compliance and Leadership.
• Represents the Company at the local Regulatory Authority(ies).
• Partner with Regulatory Policy to develop and reinforce Pfizer regulatory positions with external stakeholders and understanding of the external environment.
• Understand local regulations and developing trends in the local regulatory environment of the countries under responsibility and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies, and decision making. Influence on new legislation initiatives that could impact the business.
• Active participation in the local Trade Association(s) and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business.

RESOURCES MANAGED

Head of Regulatory Sciences

Regulatory Sciences Manager, Coordinator, Analyst

Administrative Assistant

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

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