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Head of Regulatory Sciences
hace 1 mes
Job Summary
- This is a Senior Manager position who will lead, manage and provide strategic direction to the country regulatory team.
- Accountable for all strategic regulatory activities for the country including pre
- and post-authorization product lifecycle activities and delivery of operational regulatory activities in partnership with above-country operational hubs.
- Deliver 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 and 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)
Job Responsibilities
Leadership and Strategic Role
- Lead and manage the country team in the development of regulatory strategies for registration of new products and line extensions, 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 country business objectives.
- Responsible for the leadership, development, and performance management of the 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 country are managed in compliance with Pfizer standards and international/local regulations.
Internal Partnerships
- Develop strong partnerships within the country (e.g. Country Manager, Medical, Marketing, Supply Chain, 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) 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 country leads to align on regulatory positions on pan-portfolio or policy topics for communication to in-country internal and external stakeholders.
Operational Excellence
- Ensure internal regulatory processes and procedures are followed according to Pfizer policies and procedures and support compliant regulatory activities.
- Assure local licenses in country under responsibility are maintained (e.g. Marketing Authorizations) in compliance with local regulations and following corporate policies, regulatory processes and SOPs (e.g. CMC change control, product labelling, single channel of communication, etc.)
Clinical Trials
- Oversight of local Regulatory Authority submissions and approvals for Pfizer sponsored Clinical Trials and the maintenance of approved CTAs.
- Ensure Country Regulatory Strategy accountabilities are fulfilled as defined in Alliance Partner Task Ownership Matrix.
Qualifications/ Skills
- 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, preferably on human medicines. Proven ability to manage complex regulatory issues.
- Demonstrable knowledge across the Drug, Discovery, Development, and commercialization lifecycle, with proven examples of contribution.
- 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.
- 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
- Member of the Latin America Regional Leadership Team.
- Member of Country Medical Council (CMC), as applicable.
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 Lead
