Regulatory Affairs Head

3 weeks ago

Johannesburg, South Africa GSK Full time

**Site Name**: South Africa - Gauteng - Johannesburg

**Posted Date**: May 13 2024
**Job Purpose**:
Lead the regulatory team responsible for the South African Market, to ensure access to medicines, contributing to growth and profitability of GSK business, protecting reputation and ensuring regulatory compliance in the market, in alignment with local regulations, GSK Regulatory Affairs objectives, policies and standards as well as with commercial objectives.

Lead and shape the regulatory strategy, governance and operations for South Africa, including coordination of aligned Global Regulatory Content Delivery (CD) team activities, management and oversight of 3rd party contractors.

Interface with the South African Regulatory Authority (SAHPRA) on NPI, Labelling and CMC regulatory issues / follow-ups (where applicable).

To ensure that all regulatory processes are developed and implemented, ensuring continuity of supply and conformance to applicable regulations and regulatory standards.

**Key Responsibilities**:

- Establish strategic direction for all regulatory processes in South Africa in alignment with GRA objectives, Partner Markets Commercial strategies, and priorities.
- Leadership and coordination of regulatory affairs activities completed in LOC and operational matrix (Regional Regulatory Strategy (RRS), Global Regulatory Content Delivery and in alignment with EM Partner Markets Head.
- Provide regulatory input to stakeholder functions to achieve optimal regulatory approval timelines and to maintain regulatory compliance.
- Obtain early regulatory approval for product changes required to maintain supply continuity and remain competitive.
- Identifies areas of opportunity and risks related to regulatory activities for GSK.
- Create mitigation plans to eliminate or minimize foreseeable regulatory related risks.
- Ensure personal and professional development of local regulatory affairs staff through coordinated, well managed, strategically aligned programme that utilizes the development plans and talent review processes thereby ensuring that the best people with the right skills are in place to support product registration in the LOC in the short term and that a succession stream is developed for the longer term.
- Engage with management in workforce planning for Regulatory Affairs and provides guidance to ensure effective resourcing for the achievement of regulatory targets.
- Analyse LOC RA team performance regularly and provides timely and accurate reports of LOC performance to Regional Regulatory.
- Ensures the appropriate maintenance of records in GSK databases (e.g. Veeva Vault) to ensure that all regulatory processes and information (i.e., marketing approvals, variations, renewals and labelling) are traceable and aligned with local regulations and corporate policies and procedures.
- Ensure effective onboarding and oversight of Regulatory Contracted workers. Lead regulatory governance in South Africa, ensuring responsibilities relating to regulatory conformance (local regulations, corporate policies, procedures and relevant guidance’s) are adhered to. Ensure an effective regulatory internal control framework is in place and adhered to:

- implementation and management of GRA KPIs
- effective risk & issue management and mitigation
- compliance with written standards and Training
- compliance with Audit & Assessment programs
- Facilitate the strategic development and deployment of regulatory projects through prioritization, allocation of resources and enabling communication across teammates within South Africa, at the area and global levels. Responsible for Regulatory budget as needed.
- Ensure appropriate advocacy strategies are in place to shape evolving legislation / regulatory requirements (where applicable) in partnership with relevant stakeholders (Regulatory Policy & team, local trade associations, Third Parties).
- Responsible Pharmacist (RP) roles & responsibilities.

**Key Requirements**:

- Bachelors Degree in Life Sciences
- Min. 7 years of relevant experience in Regulatory Affairs of which a considerable part has been in leadership /management positions.
- Knowledge of the policies and regulatory climate in South Africa.
- Experience gained across multiple markets is preferable.
- Experience of working effectively in a matrix across functions.
- Deep understanding of the end-to-end project from Business case to Product supply (including Regulatory submission and approval, artwork support, documentation for importation, and all activities that Regulatory support is needed).
- Strong management and project leadership skills, ability to provide advice and counsel to company staff in strategic decisions.
- Strong business management capabilities (change management, business partnership, business acumen).
- Experience of working with Regulatory Third Parties is preferable
- Effective collaboration and negotiation with regulatory authorities.
- Work in complex regulatory environment. Able

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