Senior Regulatory Affairs Specialist

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 EnglishPortuguese 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 proofreading and approval of Country labeling text mockups 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 headoffice 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) backup:

• 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.

Qualifications :

• Bachelor of Pharmacy degree is must;
• At least 23 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.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

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