Job Title: Head Regulatory Affairs, South Africa
Requisition Number: 16528
Country: South Africa
State: N/A
City: Johannesburg
Location: Cambridge
Functional Area: REGULATORY
Position Type: Regular
Full-Time / Part-Time: Full-Time
Shift: Days
Specific Responsibilities: Specific Responsibilities:
Registration:
Primary contact with national authorities for any regulatory issues regarding Gilead’s licences.
Liaison with International Regulatory Affairs regarding the preparation of any submissions relating to Gilead’s products (including clinical trials, NCEs, variations and line extensions), both for licences held by Gilead, and those licences in South Africa held by Distributor Partners.
Submission and follow-up of all regulatory submissions to national authority.
Liaison with Global Drug Safety & Public Health and International Regulatory Affairs regarding submission of PSURs, urgent safety restrictions and safety variations for national products.
Submission and coordination of distribution of Dear Healthcare Provider Letters.
Submission of Clinical Trial Authorisation applications and subsequent applications (amendments etc).
Submission of updated product labelling to national compendia.
Obtain and maintain necessary regulatory-associated licences and obligations with national agencies in order to allow Gilead to conduct its business.
Provision of accurate English translations of all agency correspondence and labelling for Gilead’s products in South Africa, as necessary.
External Liaison and Strategy in Assigned Territories:
Establishment of good working relationships with national authorities.
Establishment of good working relationships with regulatory groups of commercial partners/CROs in South Africa.
Provision of strategic regulatory advice regarding national registration requirements to senior management and International Regulatory Affairs.
Communication to International Regulatory Affairs and Drug Safety & Public Health of any new or changed national regulatory legislation/guidance/situation which may affect Gilead’s regulatory or pharmacovigilance strategy.
Participation in agreed industry working groups.
Commercial Compliance Activities:
Having oversight of the provision of scientific information about Gilead’s medicinal products in the territory.
Establishing and maintaining in conjunction with local General Manager, Medical Affairs, Legal and Regulatory Compliance, a programme of training and auditing of the provision of medical information and adherence to legislation, codes of practice and Gilead internal guidelines concerning promotion and advertising of Gilead’s medicinal products.
Ensuring in conjunction with General Manager and Medical Affairs that Sales Representatives in country (both Gilead and commercial partners) transmit any new information to Medical Affairs given to them by health care professionals about the use of Gilead’s products that would add to the body of knowledge about that product.
Provision of guidance and assistance to Marketing (both Gilead and commercial partners) during preparation of promotional material.
Review and approval of promotional material in accordance with the Gilead internal promotional guidelines, national legislation and Codes of Practice.
Ensure provision of updated approved product labelling to relevant personnel, for all products.
Regulatory Compliance:
Coordination and preparation for local authority inspections.
Preparation and maintenance of SOPs and associated process documentation as required of regulatory affairs, internally and externally.
Act as Records Retention coordinator for the appropriate maintenance and storage of information according to agreed records retentions schedules for regulatory affairs.
Quality:
Review and approval of packaging materials in line with approved licences and Gilead’s internal processes.
Liaison with Gilead Sciences regarding introduction of packaging for assigned territories. Liaison with Marketing regarding artwork changes.
Pricing & Reimbursement:
Provide regulatory guidance and input as required to support Gilead’s pricing strategy and negotiations with the authorities in order to obtain optimum pricing.
Prepare or oversee preparation of required regulatory documentation to support the agreed pricing and reimbursement strategies
Pharmacovigilance Responsible Person
Acts as responsible person for pharmacovigilance with Drug Safety and Public Health.
Assist Drug Safety & Public Health in training relevant personnel regarding adverse event reporting.
Fulfils role of Pharmacovigilance responsible person in line with requirements of South African Regulatory Authority to enable Gilead Sciences South Africa to hold product licences.
Management and Administration
Perform all required reporting obligations.
When applicable recruit staff.
Support the individuals and teams in other functions in the performance of their duties for the South African country office as required.
Provide Regulatory Affairs input to crisis and incident management and business continuity planning and events, as required.
Essential Duties and Job Functions: Must have an extensive knowledge of regulatory requirements, including ICH requirements and national requirement for South Africa and have an understanding of current global, regional and national trends in Regulatory Affairs and ability to assess the impact of these requirements to the business.
Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities. Demonstrated ability to act as primary Gilead contact with Regulatory Authorities. Ability to manage complex relationships with distributors and agencies with the required tenacity and flexibility of style.
Must be capable of taking a leadership role in providing regulatory advice and in updating and preparing Gilead for changes in legislation in assigned territories.
Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidances are met for assigned product(s) and territories. Prepare and/or manage others’ submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs. Responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories. Responsible for ensuring preparation of the Product Company Core Data Sheets (CCDS), regulatory review of draft Product Company Core Safety Information (CCSI) and ensuring that any updates to the CCDS or CCSI are implemented in a timely manner. Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license. Acts as project team representative and may act as submission team representative for specified products. Represents Regulatory Function at internal meetings. Works proactively to build contacts with local Regulatory Authorities. Participates in industry trade groups and regulatory affairs professional societies. Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management. Initiates or contributes to local and / or global process improvements which have a significant impact on the business.
Knowledge, Experience and Skills: Typically requires a BA degree in a relevant discipline and minimum 12 years of relevant experience in regulatory affairs. An advanced degree is desirable. Previous people management experience and direct experience working with Regulatory Authorities in assigned territories is required. Experience representing Regulatory Affairs on project teams is mandatory. Excellent verbal, written, negotiation and interpersonal communication skills are required. Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities. Excellent influencing and negotiation skills. Must be capable of taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments. Must be capable of leading one or more teams in preparation of submissions and maintenance of licenses. Work is performed under consultative direction towards corporate regulatory goals and objectives. Schedules and arranges own activities and those of direct report(s) (if applicable). Is recognized as an expert resource for Regulatory Advice in other departments.
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