Senior Regulatory Affairs Specialist

Abbvie Inc; Gauteng; Hybrid; ZAR 400,000 - 600,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Regulatory Affairs Specialist to manage product registrations and ensure compliance with health authority regulations in Africa. The role requires strong expertise in regulatory processes and offers a hybrid work format, ideal for a professional with a Bachelor of Pharmacy degree and experience in regulatory affairs.

Qualifications

• At least 2-3 years' experience in regulatory affairs.
• Knowledge of current legislation and pharmacology.
• Courses in Medicine Registration and Advertising Medicines.

Responsibilities

• Ensure timely approval of regulatory submissions.
• Maintain existing product marketing authorizations.
• Train affiliate staff on regulatory processes.

Skills

Regulatory Compliance

Technical Support

Project Planning

Education

Bachelor of Pharmacy degree

Tools

Microsoft Office

Lotus Notes

Docubridge

Job description

Company Description: AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us.

Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description Summary

Responsible for ensuring that new products are registered and existing registrations are maintained in accordance with the current requirements of the various Health Authorities in Africa.

End-to-end regulatory management of portfolio including product registration, labeling, promo material approval, and compliance with legislation.

Brand team support, providing advice and guidance.

Complete responsibility over product portfolio in South Africa and in English-Portuguese Africa with regulatory oversight of medicines and devices in Kenya and Ethiopia. The position assumes a hybrid work format.

Responsibilities

1. Advance Pipeline / Marketed Product Support: Submissions, Renewals & Approvals: Ensure timely preparation, filing, and approval of all regulatory submissions to meet business targets.
2. Work with agents in-country to expedite approvals of new applications and variations; maintain all existing product marketing authorizations and gain approval for variations.
3. Stay updated on emerging legislation and guidelines in Kenya and Ethiopia; maintain licenses in Region Africa, including GMP licenses related to the product portfolio.
4. Update RA activities in all systems; review and update package inserts, ensure compliance with CCDS requirements and IFU, and manage related submissions and approvals.
5. Create, proofread, and approve country labeling text, mock-ups, and artworks; notify immediately of any regulatory requests or safety labelling changes.

Compliance / Training

• Ensure compliance with statutory local, regional, and AbbVie regulations.
• Provide technical support to Affiliate Safety Representatives and QA.
• Maintain regulatory trackers for products and portfolios; review and approve promotional materials from a regulatory perspective.
• Manage CCDS and label change control databases; provide monthly status reports.
• Support regulatory communication and management activities for the product portfolio.

Regulatory Excellence & Organisation Transformation

• Coordinate with manufacturing sites and other departments; ensure regulatory effectiveness.
• Participate in local brand teams to support product development, project planning, and market support.
• Lead advocacy efforts for the product portfolio.

People / Talent

• Train affiliate staff on relevant regulatory processes.

Affiliate Quality Assurance (QA) Backup & Pharmacist Deputising

• Ensure compliance with Quality Assurance regulations; deputise as Responsible Pharmacist as per Pharmacy Act.

Qualifications

• Bachelor of Pharmacy degree is mandatory.
• At least 2-3 years' experience in regulatory affairs or equivalent.
• Experience with pharmaceutical product marketing.
• Courses in Medicine Registration, Advertising Medicines, and related subjects.
• Proficiency in Lotus Notes, Microsoft Office, Docubridge.
• Knowledge of current legislation and pharmacology.

Additional Information: AbbVie is an equal opportunity employer committed to diversity and inclusion, operating with integrity and driving innovation.