Senior Regulatory Affairs Lead — Global Submissions Remote

Placements24

Gqeberha

Hybrid

ZAR 1,000,000 - 1,600,000

Full time

5 days ago

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Job summary

Placements24 is seeking an experienced Senior Regulatory Affairs Specialist to lead regulatory submissions and strategies for pharmaceutical products in the Port Elizabeth region. You will collaborate with R&D, quality, and commercial teams to develop robust regulatory plans and ensure timely market access.

The ideal candidate holds a Bachelor's or Master's degree in a relevant field, has at least 6 years of regulatory affairs experience, and a proven track record of successful submissions and

Qualifications

Bachelor's or Master's degree in a related scientific field.
Minimum 6 years of pharmaceutical regulatory affairs experience.
Proven track record of submissions/approvals in major markets.
Strong knowledge of global regulatory guidelines and submission requirements.

Responsibilities

Develop regulatory strategies for product registration and lifecycle management.
Prepare and submit dossiers (CTD, ANDA, NDA) to health authorities including SAHPRA.
Liaise with regulatory agencies and manage the submission process.
Ensure compliance with regulations, guidelines, and company policies.
Provide regulatory guidance to cross-functional teams and monitor changes.

Skills

Regulatory strategy

Dossier submission

Regulatory liaison

Project management

Communication

Education

Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related field

Job description

The ideal candidate holds a Bachelor's or Master's degree in a relevant field, has at least 6 years of regulatory affairs experience, and a proven track record of successful submissions and

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