Descrição da Vaga
The Head of Regulatory Affairs for a country will lead, manage and provide strategic direction and oversight to the country based regulatory teams that give support to develop and execute regulatory strategies and plans for the country, where applicable. The Head of Regulatory Affairs would represent Regulatory at the country General Manager forums, local Country Medical Council (or equivalent) and local and regional S&OP; to ensure collaborative connectivity with these key stakeholders (e.g. Commercial, Supply Chain, Quality, Medical, etc.), and a more focused regulatory approach to supporting country business objectives.
- Lead and manage the RA team under their responsibility in the development of regulatory strategies to support the registration of new products, line extensions, major variations and lifecycle management. Ensure that RA team under their responsibility provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives.
- Develop strong partnerships with in-country or cluster partners (e.g. General Managers, Medical, Marketing, Supply Chain, Quality), Regulatory regional teams and above country Regulatory to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
- Provide strategic contribution to the country or cluster markets to achieve business objectives.
- Responsible for the development, leadership and performance management of the RA team to achieve company objectives. Develop and enhance the capabilities and capacities of the RA teams through the identification and implementation of training and development needs.
- Responsible for developing and enhancing relationships with key external agencies (HA's/BoH, RKOL's, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product, developing a long-term and positive relationship characterized by Integrity, Quality, Compliance and Leadership. Face before the MOH authorities
- Active participation in trade organization of countries of responsibility and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand local regulations and developing trends in the local regulatory environment of the countries that support 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 sanitary legislation initiatives that could impact the business
- Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations of the countries that give support by ensuring that corporate regulatory processes, SOP's and systems (e.g. CMC change control, product labelling, etc.) are in place, and that the local RA staff (permanent and contract) are properly trained in these systems and procedures.
- Oversee and manage the completion of NDA and Lifecycle (LC) submissions and approvals as per established Regulatory performance metrics.
- Responsible for assuring GMP Compliance according to current Country regulations, where applicable.
* 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.
* Communication skills
* Negotiation skills
* Problem Solving
* Understands Business and Financial Environment
* Understands Pharmaceutical Industry
* Understanding stakeholder needs
* Network and alliance building/ peer relationships
* Growth focused and change agile
* Team working
* Interpersonal acumen
* Organizational agility
* Strong quality and compliance orientation
* Analytical Thinking
* Leadership and Management
* Talent Development
* Scientific Degree. A higher degree (MS or PhD) may be an advantage but is not essential. Pharmacist degree may be mandatory in some countries.
* Appropriate Regulatory Experience – minimum 10 years experience
* Management Degree (Diploma or MBA) may be an advantage
* Demonstrable experience 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.
* Regional regulatory experience including knowledge of CTA's and NDA 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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.