Purpose: The role involves ensuring that all products comply with regulatory requirements set by authorities and align with internal policies and business strategies. The individual is expected to provide strategic input for regulatory processes, contribute to the development of new products, and actively engage in regulatory discussions and updates.

Responsibilities:

Strategic Support and Innovation:

· Provide expert consultation on regulatory requirements, including verifying strategies and timelines.

· Manage a range of regulatory activities, such as new product registrations, updates, renewals, and compliance submissions.

· Develop and implement regulatory strategies in collaboration with regional and local teams.

· Work with medical and regulatory teams to ensure timely submission of products aligned with project timelines.

· Coordinate and oversee the implementation of strategic and operational regulatory activities for assigned projects.

Product Maintenance and Compliance:

· Ensure ongoing maintenance of product registrations and manufacturing site compliance.

· Update internal systems and databases promptly following company procedures.

· Manage packaging and labeling processes, ensuring adherence to local regulatory requirements.

· Oversee translations and document archiving, ensuring accessibility and compliance with local and global systems.

· Review and approve both promotional and non-promotional materials, ensuring they meet market-specific regulatory standards.

Stakeholder Collaboration and Issue Resolution:

· Act as the primary contact for regulatory submission processes, addressing issues and escalating concerns as necessary.

· Coordinate submission documentation and ensure proper tracking and communication with relevant teams.

· Provide updated regulatory requirements and insights to global and regional teams to support compliance and documentation preparation.

· Identify gaps in regulatory documentation and collaborate with quality assurance teams to address deviations and establish corrective actions.

· Monitor submission statuses, escalate risks, and communicate regulatory updates across relevant functions.

Representation and Additional Duties:

· Represent the organization in interactions with government authorities and industry associations.

· Handle other tasks assigned by regulatory leadership.

Scope of Responsibility:

· Collaborate closely with local and regional colleagues across multiple functions.

· Ensure compliance with internal policies, regulatory standards, and local requirements.

Qualifications and Skills:

· Solid experience in regulatory roles within the pharmaceutical or healthcare industry.

· In-depth knowledge of regulations governing pharmaceuticals, health supplements, and cosmetics.

· Fluency in English and proficiency in regulatory processes, quality systems, and risk management.

· Strong skills in project management, strategic thinking, problem-solving, communication, and leadership.

Educational Background:

· A degree in Pharmacy, Pharmaceutical Sciences, or a related scientific field is required.