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Regulatory Affairs Director

1 month ago

Midrand, Gauteng, South Africa Emporium Full time

At Emporium, we are seeking a highly skilled Regulatory Affairs Director to lead our OTC division. As the Head of Regulatory Affairs, you will be responsible for overseeing the development and delivery of a fully integrated regulatory strategy for the business.

The successful candidate will hold ultimate responsibility for the OTC division's regulatory activities and will oversee the Group Stability Department. This role requires a high degree of networking and collaboration both within and outside the organisation.

To be successful in this position, you will need to have a minimum of 8 years of pharmaceutical regulatory experience and a B. Pharm Degree Registration with South African Pharmacy Council. You should also have a minimum of 5 years in people or team management.

The salary for this role is estimated to be around R 1,700,000 – R 1,800,000 per annum.

Key Responsibilities:

• Drive the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.

• Adopt a risk-based assessment for all regulatory submissions and formulate regulatory risk mitigation strategies, as applicable.

• Anticipate, communicate and manage future regulatory changes and impacts on business success.

• Communicate effectively to ensure an excellent understanding of Regulatory Affairs.

• Pay strict attention to detail and accurately monitor and measure progress towards objectives and provide feedback on results while maintaining a sense of urgency.

• Strive to maintain a high level of quality and ensure superior execution by combining the best regulatory practices.

• Represent RA at operational meetings such as Group Regulatory, Technical Transfer, QA, Operations, Launch, Artwork/Packaging, Stability and Research & Development.

Requirements:

• Proven track record of successfully leading regulatory teams and driving compliance objectives.

• Excellent communication and interpersonal skills.

• Strong analytical and problem-solving skills.

• Ability to work in a fast-paced environment and adapt to changing priorities.

What We Offer:

Emporium offers a competitive salary package and opportunities for career growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.