Pharmacist - Regulatory Affairs

About

An established leader in the pharmaceutical industry has an opportunity for an experienced (2 to 3 years of RA dossier compilation) pharmacist to join their Regulatory team.

Work Arrangement

Hybrid in office / work from home (1 to 2 days a week from home, after the first 3 months in office)

Experience

Ideally, you have experience in:

• product development,
• commercialisation
• maintenance lifecycle

… and experience in quality-driven processes such as:

• risk management,

• change control,

• deviations,

• CAPA’s,

• Root cause investigation

• Additional experience in African territories is an advantage

• Project management capabilities are an advantage

Duties & Responsibilities

Job Purpose:

Support the Regulatory Affairs team to provide superior Regulatory services.

Manage a portfolio of product dossiers.

Ensure legal and regulatory compliance with the relevant medicine Regulatory Authorities (Country -specific where applicable).

Key Job Outputs:

• Manage work streams for, and report on the assigned portfolio of products
• Assisting with internal product queries from relevant departments
• Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders
• Establish regulatory priorities and allocate resources and workloads
• Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
• Artwork reviews and approvals

Coordination and submission of new product applications in South Africa and other applicable territories, including but not limited to:

• Develop regulatory strategies and implement plans for the preparation and submission of new products
• Conduct dossier due diligence to ensure all data gaps are addressed
• Prepare the registration applications for submission to the regulatory authorities
• Work in collaboration with internal and external stakeholders to assess the regulator’s submission requirements
• Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines

Desired Experience & Qualification

• Bachelor’s degree in pharmacy
• 2+ years’ experience in Regulatory Affairs and dossier compilation of new products, preferably in human medicines

Package & Remuneration

Salary is negotiable and will be influenced by factors such as your specific experience and skills in regulatory affairs, your qualifications,etc. A salary package of about R900k to R1 million per yera is envisaged for this role.

(About R70k to R75k ctc per month, plus a guaranteed 13th cheque).

Interested?

Please use reference P20 RAP

Please apply directly on this PNet portal.