Job Description

A global pharmaceutical company is seeking a Regulatory Pharmacist to be 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.
• 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 labelling 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 corporate regulations
• Provide technical support to Affiliate Safety Representative (ASR) and QA. - Maintain all regulatory trackers for PRODUCT 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 AFFILIATE departments.
• Coordinate and ensure effectiveness of Regulatory Affairs function.
• Transforming the Organisation: FutureFit/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.
• Take the lead on advocacy for product portfolio
• Ensure training of AFFILIATE staff on relevant Regulatory processes.
• Main responsibilities as Affiliate Quality Assurance (QA) back-up (if relevant): - Fulfil National Regulatory Authority regulations with respect to Quality Assurance and conform to the company standards.
• Deputise as Responsible Pharmacist when the Responsible Pharmacist is away as per section 22 of the Pharmacy Act for Allergan until integration with company
• General Responsibility: To comply with the companys policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of company.
• Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent schedule.
• Responsible for presentation and accuracy of documentation submitted to regulatory authorities.
• This is a position in which, with appropriate supervision, a significant level of autonomy is anticipated along with project responsibility.
• Accountable to Regulatory Affairs Director South Africa and Region Africa.

Requirements:

• Bachelor of Pharmacy degree (or equivalent qualification).
• Tertiary courses in Medicine Registration, Advertising Medicines and other related
• 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
• At least 2-3 years experience in the regulatory affairs environment
• Exposure to the marketing of products in the pharmaceutical environment

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.comShould you receive no feedback within 7 days, please accept your application as unsuccessful.

MNA Recruitment