Country Regulatory Affairs Associate- Tanzania, Uganda and Rwanda

Basic QualificationsBachelor of Science and/or a Diploma

Preferred QualificationsLife science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)

Diploma in Pharmacy.

A minimum of 3-5 years experience in Regulatory Affairs.

DetailsThis position has responsibility for Regulatory Affairs in defined portfolios or activity streams or countries. The role may also have responsibility for leading a team of regulatory professionals within their country. This includes

Ensure products within scope (inc medicines, devices, cosmetics and foods) can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans

Ensure products are maintained and meet internal and external compliance requirements

Be a productive part of defined local regulatory team, including being a proactive partner to other stakeholders, eg, area regulatory team, marketing/sales within local commercial business, supply chain and quality etc. Lead a team of regulatory professionals if required.

Ensure products within scope (inc medicines, devices, cosmetics and foods) are maintained with optimal yet compliant claims, advertising and promotion in line with commercial plans and relevant technical updates in collaboration with Area marketing and relevant teams.

Engage with the external regulatory environment within defined area of responsibility and act as a responsible voice of GSK CH with local regulators, trade associations and other key external regulatory bodies.

Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives.

Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope

Key Responsibilities

Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market

Analyse regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and plans to mitigate, so that we can deliver products backed by science that are robust and aligned with business needs

Actively contribute to high performing teams, including looking for ways to improve performance. May lead direct reports or cross-functional teams within local market

Build relationships with key stakeholders and represent GSK in a responsible manner according to company values, in order to communicate GSK CH policies and strategies and negotiate outcomes

Manage compliance within defined portfolio/activity streams in line with GSK CH expections - support key processes and ways of working (eg, in relation to GSK CMC, quality, product labeling requirements as well as local MoH regulations). Propose solutions to identified issues and implement

Collaborative working together with other functions ( eg, marketing, supply chain) to deliver agreed NPD and value engineering projects

Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated

Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business

Maintain required regulatory compliance databases, systems and processes. Train other compnay stakeholders as required to build knowledge and compliant utilisation

Maintain high level of knowledge on the science of products within defined portfolio You may apply for this position online by selecting the Apply now button.

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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Contact InformationYou may apply for this position online by selecting the Apply now button.

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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Bachelor of Science and/or a Diploma Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)

Diploma in Pharmacy.

A minimum of 3-5 years experience in Regulatory Affairs. This position has responsibility for Regulatory Affairs in defined portfolios or activity streams or countries. The role may also have responsibility for leading a team of regulatory professionals within their country. This includes

Ensure products within scope (inc medicines, devices, cosmetics and foods) can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans

Ensure products are maintained and meet internal and external compliance requirements

Be a productive part of defined local regulatory team, including being a proactive partner to other stakeholders, eg, area regulatory team, marketing/sales within local commercial business, supply chain and quality etc. Lead a team of regulatory professionals if required.

Ensure products within scope (inc medicines, devices, cosmetics and foods) are maintained with optimal yet compliant claims, advertising and promotion in line with commercial plans and relevant technical updates in collaboration with Area marketing and relevant teams.

Engage with the external regulatory environment within defined area of responsibility and act as a responsible voice of GSK CH with local regulators, trade associations and other key external regulatory bodies.

Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives.

Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope

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