Senior Regulatory Affairs Pharmacist

SUMMARY:
Isando

POSITION INFO:

Position Summary and Objective:

Responsible for the regulatory management of South Africa and some Southern African markets like Botswana and Namibia for an allocated part of the companys generic portfolio of products. Future markets and portfolios of products could be included as well as regulatory harmonization occurs.

Provide oversight for assigned countries for the portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans in support of new registrations and post-approval submissions.

Ensure regulatory input is communicated to the regional and local Commercial, Supply Chain, and Quality teams for promoting and developing products and the implementation of special projects.

Ensure and supervise that regulatory documentation meets relevant regulatory requirements.

To apply knowledge and best interpretation of regulatory requirements in the assigned countries to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.

Ensure business continuity between Global Regulatory Strategists, Country Regulatory staff and distributors supporting regulatory activities on behalf of the company.

Min Requirements:

• Bachelor’s degree in pharmacy, registered with the South African Pharmacy Council.
• MSc, MBA, or PhD may be an advantage.
• Experience in regulatory affairs, preferably in human medicines - minimum 8 years of experience.
  

Primary Responsibilities:

Direct management of part of the portfolio for South Africa and the Southern African markets. Requires close collaboration with the regulatory personnel in the Sub-Saharan African region.

Apply regulatory expertise for assigned countries to enable the preparation of high-quality documentation and assure compliance with departmental procedures.

Maintain a knowledge base of countries''''''''requirements and regulatory environments.

To build regional relationships with stakeholders/partners and assist team members to do the same with local stakeholders/partners and ensure communication/clarity of regulatory strategy and timelines.

Manage the performance of direct reports, (where applicable) to achieve agreed objectives and to identify and address training and development needs.

Provide input to the regulatory strategy for the development of products in line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development) and alignment is achieved between regulatoryactivities and relevant country business/commercial plans.