Regulatory Affairs Head

4 weeks ago

Johannesburg, South Africa 683 GlaxoSmithKline South Africa (Pty) Limited Full time

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 to anticipate possible changes in the regulatory environment (relating to product development, NPI, and market access) proactively, to monitor their implementation, to assess and communicate possible risks and to prepare the mitigation strategy. Fluent English language skills (speaking and writing). Well-developed and demonstrable skills working as a member of a multi-functional team. Ability to multitask and excel in cross-functional settings and to manage multiple issues in a fast-paced environment. The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management

Closing Date: 20 May 2024

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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