Job Description

A leading pharmaceutical company has a 2.5 year Project role for an Regulatory Affairs Pharmacist.
Job Summary:

• Responsible for the regulatory management of South Africa and some Southern Africa markets like Botswana and Namibia for an allocated part of the companies portfolio of products. Future markets and portfolio of products could be included as well as regulatory harmonisation 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.
• To ensure regulatory input is communicated to the regional and local Commercial, Supply Chain and Quality teams for promoted and development products and the implementation of special projects.
• To 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.
• To ensure business continuity between Global Regulatory Strategists, Country Regulatory staff and distributors supporting regulatory activities on behalf of the Company.

Primary Responsibilities:

• Management of assigned portfolio of products for South Africa and the Southern Africa markets.
• Apply regulatory expertise for assigned countries to enable preparation of high-quality documentation and assure compliance with departmental procedures.
• Maintain knowledge base of countries requirements and regulatory environments.
• To build regional relationship with stakeholders/partners and assist team members to do the same with local stakeholders/partners and ensure communication/clarity of regulatory strategy and timelines.
• 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 regulatory activities and relevant country business/commercial plans.
• Promote team spirit/activities in alignment with company culture and values to help retain/attract talents.
• Provide input and liaise with Global Regulatory, Regulatory Science/CMC, Supply Chain, Submissions Management, other Country Offices, Labelling teams, Artwork centres, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and Health Authority's requirements are met, ensuring a submission ready dossier. Responsible that the appropriate regulatory systems and database are updated in a timely manner when changes occur. Ensure a submission planning and forecasting tool is utilized to update timelines.
• Facilitating and support all product lifecycle regulatory work, and liaise with Regulatory Science/CMC, Submissions Management, Cluster/Markets, and any other key stakeholders.
• Ensure and oversee the preparation of regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
• Ensure adequate input to the local/regional company commercial strategic planning process as appropriate.
• Develop detailed understanding of regulatory guidelines and technical requirements and support maintenance of regulatory requirements database and assist Regulatory Policy with assessing the regulatory environment and identifying relevant trends.
• Regularly follow up with markets and distributors, if applicable, on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.

Requirements:

• Bachelor's degree in Pharmacy, registered with the South African Pharmacy Council as a Pharmacist
• Experience in regulatory affairs, in human medicines - minimum 3 years of experience.

Key Knowledge and Skills required:

• Completion of a Medicines Registration Course would be an advantage
• Experience in registration of products and regulatory knowledge on South Africa, Botswana and Namibia market guidelines.
• Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
• Proven ability to manage complex Regulatory issues and consistently deliver to time, cost and quality standards.
• Regional Regulatory experience including knowledge of NDA, multisource product applications, and product lifecycle management processes.
• Demonstrate experience of effective delivery in a complex matrix environment.
• Knowledge of Regional Regulatory environment
• Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
• Knowledge of drug development, regulations and guidelines
• Strong leadership qualities, including excellent communication, negotiation, and interpersonal skills
• Understanding of pharmaceutical industry, clinical trials and pharmacovigilance
• Knowledge and understanding of quality systems, processes, audit and inspection
• Ability to influence at all levels in the organisation
• Able to simplify complex ideas and processes
• Team player
• Growth focused
• Analytical thinking

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com
Should you receive no feedback within 7 days, please accept your application as unsuccessful.