Senior Regulatory Affairs Specialist

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 at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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 but not limited to product registration, labelling, 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:

Advance Pipeline/ Marketed Product Support: Submissions, Renewals & Approvals:

• Ensure that all regulatory submissions (new applications and variations) are prepared, filed and approved in a timely manner to meet business targets covering the respective products in Country. Work with agents in Country to gain speedier approvals of new applications;
• Maintain all existing product marketing authorisations and gain regulatory authority approval for the variations of these authorisations. Work with agents in Country to gain speedier approvals of variations;
• Keep abreast of emerging legislation, guidelines in Kenya and Ethiopia and highlight the potential impact on the business;
• Maintain licences in Region Africa including any GMP licence (Region Africa)  related to the product portfolio;
• Update RA activities in all systems;
• Review and update package inserts in line with CCDS requirements and IFU ensuring an end to end process which includes MOH submission and approval, translations, systems documentations, GLS, awareness at the affiliate and Change control in the artwork management system;
• Creation, proof-reading and approval of Country labeling text, mock-ups, artworks in artwork management system;
• Notify immediately of awareness of any regulatory requests, including safety labelling changes, urgent safety restriction requests, as well as external inspections;
• Support regulatory colleagues when necessary.

Compliance/Training:

• Ensure compliance with statutory local, regional, and AbbVie corporate regulations;
• Provide technical support to Affiliate Safety Representative (ASR) and QA;
• Maintain all regulatory trackers for products and Country portfolio to ensure real time monthly updates;
• Review and approve local promotional material from Regulatory perspective and in line with the South African Marketing Code and registered prescribing information;
• Communication of regulatory submissions and approvals via regulatory systems;
• Manage CCDS database for product portfolio;
• Manage label change control database and provide monthly reports on status;
• Provide support for portfolio of products to the brand teams.

Regulatory Excellence:

• Cooperate and liaise with manufacturing sites, corporate head-office and other departments;
• Coordinate and ensure effectiveness of Regulatory Affairs function.

Transforming the Organisation: Future Fit/ LRP:

• Participate in local brand teams to assist with product development and project planning to ensure that the proposed development plans account for regulatory requirements and that clinical advice is available throughout the process;
• Support business development on the market;
• Coordinate activities that assist product areas by providing support for Sales and Marketing, Product complaints and liabilities, where necessary, Medical support and information (e.g. provide explanation on SmPC when needed) to sales force, customers and end users.

Advocacy:

Take the lead on advocacy for product portfolio.

People/ Talent:

Ensure training of affiliate staff on relevant Regulatory processes.

Responsibilities as Affiliate Quality Assurance (QA) back-up:

• Fulfill National Regulatory Authority regulations with respect to Quality Assurance, and conform to AbbVie standards;
• Deputise as Responsible Pharmacist when the Responsible Pharmacist is away as per section 22 of the Pharmacy Act for Allergan until integration with AbbVie.

• Bachelor of Pharmacy degree is must;
• At least 2-3 years’ experience in the regulatory affairs environment as RA specialist or equivalent;
• Exposure to the marketing of products in the pharmaceutical environment;
• Tertiary courses in Medicine Registration, Advertising Medicines and other related subjects;
• Literacy in the following software packages: Lotus Notes, Microsoft Office, Docubridge;
• Tertiary qualification in a management discipline an advantage;
• Knowledge of current legislation governing product registration;
• Knowledge of other legal requirements impacting the regulatory environment e.g. advertising, Good Manufacturing Practice (GMP) etc.;
• Knowledge of pharmacology and therapeutics.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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