Job Description

Are you interested in a highly-visible Regulatory Affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, then this role could be an ideal opportunity for you to explore.

As a Regulatory Affairs Director, you will be responsible to: Provide regulatory, operational, and strategic support to the GSK business for marketed products and projects. Recommend, develop and implement GSK regulatory policies & strategies to maintain and maximize opportunities for both marketed and new product entries. Develop and implement registration plan in line with business strategy. Provide regulatory support and product information to all related functions. Maintain compliance to in line with corporate and local regulatory requirements. Deliver portfolio optimization objectives.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Represent Regulatory Affairs on the Leadership Team meetings and project meetings. Formulates and implements regulatory strategy/plans for any pre-market approval requirements. Ensure close collaboration with the internal and external stakeholders to ensure appropriate RA support to the LOC projects. Implement registration plan in line with regulatory and commercial strategy and local requirements by getting the necessary approvals in timely manner for new registrations (new chemical entities and line extensions). Visits to the MoH (Rabat) are required. Maintain regulatory Life Cycle Management (renewals, variations) to ensure compliance and product supply continuity. Ensure quality and compliance content of project/product specific for regulatory dossiers and Technical Files. Review appropriate scientific and strategic impact and when appropriate validate dossiers before submissions. Deliver portfolio optimization objectives to ensure no inappropriate Life Cycle Management RA costs and no losses for the sales. Represent GSK Regulatory at Ministry of Health when required. Visits to the MoH (Rabat) are required. Interpret local regulatory requirements (Directives, Regulations and Guidelines). Provide necessary advice to other departments, e.g. Marketing Medical, etc., on steps necessary to comply with potential project/product impact. Represent the Regulatory team regarding project status/GSK regulatory position/perspective by interfacing with Third parties. Visits and meetings with different third parties (e.g.: PHI, Sothema, and Saham) are required. Represent GSK in trade associations; develop, maintain and strengthen a dynamic network of key stakeholders. Meetings and visits to the trade association (LEMM) are required. Collaborate with key cross-functional team members to meet or beat all project goals. Participate actively in the Product incident management

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals: Degree in scientific discipline with a specialization (Pharmacy, Science or Medicine) Relevant industry experience in Regulatory Affairs of which a considerable part has been manager's roles in multinational companies leading regulatory activities. Experience of leading effectively at senior level, in a matrix across functions and working with diverse multi-cultural teams. The role will be in a highly complex regulatory environment, which entails: Close follow up with MoH to get timely approval. Minimize risks to the organization by avoiding recalls linked to RA activities. Proactive measures and activity for any sudden or planned MOH decision which might affect the organization. Ensure timely submission, approval and implementation of safety updates to avoid any compliance issues. Crisis Management (participation on product Recall; quality issues linked to registered details...etc). Good mastery of English Understanding of the health care system and all relevant processes and economic environment Knowledge of key GSK Policies and codes Advanced skills to handle range of complex relationships, issues, multiple projects simultaneously Proven influential skills Strong interpersonal and networking skills with ability to build and maintain relationships at all levels of GSK and external stakeholders Thorough understanding of MoH regulatory systems and rules Relevant experience in a senior regulatory role Compliance oriented Ability to formulate and lead implementation of regulatory strategy and plans to achieve efficient and competitive product registrations, label/CMC changes, pack management and artwork control Ability to effectively communicate (written and verbal) technical regulatory strategy to product/project teams, management team and key MoH contacts. Leadership expectations, including: Demonstrated ability to work independently; Demonstrated ability to work and lead effectively in matrix teams; Strong organizational skills; Strong time management skills; Demonstrated ability to effectively prioritize and identify potential issues/concerns; Demonstrated ability to influence based in facts & data; Demonstrated ability to effectively communicate team position to upper management & stakeholders.

Why GSK?

Why GSK? (the following is standard for all job descriptions depending on if the role is "New GSK")

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

Contact information: You may apply for this position online by selecting the Apply now button.

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