Senior Regulatory Affairs Manager/ Head of RA
|Location||Recruitment Agency / Vacancy in South Africa. Cape Town|
|Education||B.Pharm and registered with SAPC|
To manage all aspects of the regulatory affairs department to ensure beneficial relationship management with health authorities, efficient registration of new dossiers, effective management of existing dossiers and compliance with the latest guidelines
• B. Pharm or similar scientific degree.
• 8 - 10 years working experience in Regulatory Affairs
Technical Competencies Required:
• Extensive experience of the regulatory function in the pharmaceutical industry
• Computer literate and able to effectively use Excel
• Extensive knowledge of generic pharmaceutical market
• Manage new dossier compilation and new product registrations
• Oversee and regulate the activities of regulatory pharmacists/scientists with regard to new dossier compilation for South Africa and selected African countries
• Ensure that dossiers are submitted timeously to the MCC and followed up on regularly with MCC and other authorities in order to ensure speedily registration
• Actively build relationships with MCC and equivalent bodies in sub-Saharan countries to ensure streamlined submissions
• Provide guidance and support to regulatory pharmacists/scientists in evaluating studies and data towards registration of products, reviewing marketing materials, evaluation of dossiers prior to submission, supplier liaison etc
• Provide guidance to overseas suppliers regarding product registration in South Africa
• Provide advice on new product development and the subsequent registration thereof.
• Ensure the auditing and approval of new overseas manufacturing facilities prior to launch.
• Ensure that all data and subsequent submissions are made timorously before Council and committee meetings in order to ensure quick registration.
• To ensure that new product applications progress through registration in an efficient manner resulting in speedily approval and launch.
• Manage existing dossier maintenance
Ensure that dossiers are continually managed and updated in compliance with the latest MCC guidelines
• Ensuring that approvals are obtained from HA’s for manufacturing updates and variations including new API sources and changes to manufacturing sites.
• Manage the process of transfer of manufacturing to more cost effective factories e.g. Lupin
• Ensuring the continued development and maintenance of the EDMS (Electronic Document Management System)
• Ensuring the approval of existing overseas manufacturing facilities and local suppliers in accordance with MCC requirements
• Assist the Compliance Manager in the maintenance and updating of Standard Operating Procedures (SOP’s) and the Quality Management System (QMS).
• Management of external relationships
• Maintain a high profile with health authorities, industry bodies etc in order to positively influence perceptions of the company and its aims
• Regularly liaise and interact with health authorities both inside and outside South Africa
• Proactively develop and manage relationships with the MCC’s Operations and Admin unit to ensure effective streamlining of the company’s applications
• Negotiate / liaise on the company’s behalf with the MCC to prioritise registrations according to the business agenda
• To assist the various MCC’s committees in order to gain approval so that product registration with Council can be pursued
• Staff management
• Provide leadership and daily management to all regulatory staff
• Manage the role of the Responsible Pharmacist in order to comply with all laws, rules, regulations and codes
• Provide advice, guidance and mentorship to staff in order to grow their skills and abilities. Provide training where appropriate in this regard.
• Manage and monitor staff performance
• Manage workflow and prioritise departmental activities
Should you meet the requirements for this position, please email your CV to firstname.lastname@example.org or fax to 086 571 7307 or alternatively call on 021 551 8638.
Correspondence will only be conducted with short listed candidates. Should you not hear from us within 3 days, please consider your application unsuccessful.
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or email us: pharmacy.jobs(at)hireresolve.co.za