Türkiye Regulatory Lead

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The Regulatory Head will lead, manage, and provide strategic direction to the country-based regulatory teams, driving the development and execution of regulatory strategies and plans for the country and, where applicable, the region. This role will represent GRS on the Country Leadership Team (CLT) and local Country Medical Council (or equivalent) to ensure strong collaboration with key stakeholders (e.g., Commercial, Medical) and enable a focused regulatory approach that supports country business objectives.

Lead and manage the regulatory team in developing and executing regulatory strategies to support the registration of new products, line extensions, major variations, lifecycle management, GMP process and medical devices. Ensure that local regulatory teams provide strategic regulatory input into global regulatory strategies, aligning local regulatory activities with global objectives to achieve optimal business and compliance outcomes
Develop strong partnerships with in-country teams (e.g., Country Managers, Medical, Marketing, Supply Chain) and GRS-EM Therapeutic Area and Regional Teams to enable the development and implementation of registration strategies that expedite the approval of new products, line extensions, and lifecycle optimization initiatives.
Provide strategic contribution to the country leadership teams – anticipate what GRS-EM needs to contribute to achieve business objectives.
Responsible for building and maintaining strategic relationships with key external agencies (e.g., HAs/BoH, RKOLs) and managing the HA/BoH interface throughout the product development and lifecycle. Foster long-term, positive relationships grounded in integrity, quality, compliance, and leadership, serving as the primary liaison and main contact for local government regulators on all regulatory-related activities.
Define the overall regulatory strategy for the product registration pathway, including:
Regulatory frameworks: Identify applicable global, regional, and local regulations, standards, and classification requirements relevant to the product category.
Evaluation data: Determine the necessary preclinical, clinical, and performance data to support safety, efficacy, and quality claims for submission.
Product lifecycle management: maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems (e.g. CMC change control, product labelling, etc.) are in place, and that the regional RA staff (permanent and contract) are properly trained in these systems and procedures.
Monitor and assess local regulatory environment: Stay informed of local regulations and emerging trends, providing impact assessments to key stakeholders. Leverage regulatory intelligence and landscape knowledge to support the development and implementation of regulatory and business strategies, and positively influence local legislative initiatives affecting the business.
Oversee regulatory submissions and approvals: Manage the preparation, submission, and approval of CTA, NDA, and lifecycle (LC) submissions in accordance with established GRS-EM performance metrics.
Ensure regulatory compliance: Ensure that all regulatory activities—including new product submissions, clinical trial applications, and existing licenses—fully comply with local regulations, requirements, and practices.
Build and lead a high-performing regulatory function in Turkey, fostering regulatory excellence through:
Strategic leadership: Establish a best-in-class regulatory organization aligned with global standards and local compliance requirements.
Collaboration: Drive strong cross-functional partnerships with R&D, quality, medical, and commercial teams to accelerate approvals and market access.
Continuous improvement: Cultivate a culture of regulatory innovation, leveraging reusable blueprints, knowledge sharing, and rapid iteration to enhance efficiency and consistency across submissions and lifecycle activities.
Develop and enhance the capabilities and capacities of the regulatory teams by identifying training and development needs and implementing targeted programs to strengthen expertise and operational excellence.

Qualifications

Experience: Minimum of 15 years in regulatory affairs, including product registration and CMC management, with 7 –10 years in a people management role.

Education: Degree in Pharmaceuticals or Chemistry is a must

Regulatory Knowledge: Strong understanding of regional and global regulatory environments and their impact on regulatory strategy and implementation.

Technical Expertise: Knowledge of drug development practices, GMP inspection requirements, local regulations and guidelines.

Proven Skills: Demonstrated ability to develop and implement regulatory strategies effectively.

Leadership & Strategic Thinking:

Ability to think strategically and align regulatory initiatives with business objectives.
Excellent communication and negotiation skills
Strong problem-solving capabilities
Understanding of the business and financial environment
In-depth knowledge of the pharmaceutical industry

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

School of Leaders

We, as Pfizer Turkey, make a difference with our visionary and pioneering approaches ranging from our concept of raising leaders through rotations, providing international career opportunities to creating a flexible, enjoyable work environment. There are no limits to what we can accomplish to touch lives here!

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Regulatory Affairs

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