Regulatory Affairs Manager

Purpose of the Role

The Deputy Manager will support the strategic direction, execution, and optimization of all regulatory development activities in the country. The role ensures timely submissions, compliance with regulatory requirements, and delivery on KPIs while leading a high-performing team. A key element of the role is managing both people and processes in a highly regulated environment, driving efficiency improvements, and partnering closely with internal stakeholders and health authorities.

Responsibilities

• Lead a high-performing team and manage team capacity to ensure delivery on KPIs.
• Drive PI license applications and maintenance activities.
• Support Regulatory Affairs Management in implementing strategy to meet quality and stakeholder expectations.
• Develop and optimize the parallel distribution marketing authorization function.
• Oversee change management initiatives to increase efficiency in licensing activities.
• Ensure internal procedures are followed and continuously improved.
• Provide regulatory expertise through strong knowledge and hands-on experience.
• Stay updated on internal and external regulatory requirements and expectations.
• Focus on employee satisfaction, development, and feedback within the team.
• Serve as a point of contact with health authorities, collaborating with colleagues across the business.

The Team and Stakeholders

This is a newly established Regulatory Affairs team, responsible for all regulatory steps related to parallel trade licensing. The Deputy Manager will lead the team, ensuring timely submissions and compliance.

Internal stakeholders: Regulatory Affairs, Quality Assurance, Operations, Business Development, Production, and other cross-functional teams.

External stakeholders: Health authorities, regulatory consultants, and industry partners.

Qualifications

Specific educational or professional standards, degree, or certifications.

• Master’s/Bachelor’s degree in Life Sciences, Pharmaceutics, Regulatory Affairs, or a related field.
• Minimum 3 years of leadership experience, preferably in pharma, biotech, or pharmaceutical services.
• At least 5 years of experience in the Pharmaceutical or Healthcare industry.
• Proven track record in regulatory roles within a structured, highly regulated environment.
• Fluency in English, both written and spoken.

Skills

Abilities needed to execute tasks effectively, often divided into technical and interpersonal categories.

• Strong people management and team development skills.
• Effective communication and stakeholder management abilities.
• Ability to manage structured administrative and compliance-driven tasks.
• Knowledge of design programs (InDesign, Illustrator, Photoshop).
• Strong organizational skills with attention to detail and compliance.

Competencies

Set of behaviours and attitudes, combining skills and knowledge to perform the role successfully

• Innovative and solutions-oriented mindset.
• Clear direction setting with a collaborative leadership style.
• Strong interpersonal skills with the ability to foster a positive team culture.
• Comfortable navigating a complex, regulated environment.
• Agile and proactive in implementing process improvements.