Are you looking for a highly visible regulatory leadership role where you can build advocacy and accelerate regulatory compliance on an international scale?  If so, this Regulatory Affairs Management Director role could be an exciting opportunity to explore.

As a Regulatory Affairs Management Director, you will be responsible for leading regulatory strategy, operations, quality and risk management functions across international markets.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Establish strategic direction for all regulatory processes in regional countries (Cluster) in alignment with regional Regulatory Affairs objectives and Cluster functions (Commercial, Medical etc).
• Lead regulatory governance in Cluster. Ensure local responsibilities relating to regulatory conformance (local regulations, corporate policies and procedures) are adhered to.
• Lead the appropriate maintenance of records by the development and implementation of effective procedures to ensure that all regulatory processes and information are traceable and aligned with local regulations, corporate policies and procedures.
• Ensure an effective regulatory internal control framework is in place including appropriate processes and associated training to ensure the staff are compliant with regulatory and associated legal requirements.
• Ensure implementation of the processes and tracking of relevant metrics as defined by the Regional Regulatory Affairs Key Performance Indicators (KPIs).
• Facilitate the strategic development and deployment of regulatory projects through prioritization, allocation of resources and enabling communication across functions within Local Operating Countries (LOCs), at the cluster and area levels.
• Ensure effective recruitment and personal and professional development of the staff through a coordinated, well managed, strategically aligned program.
• Accountable for LOC regulatory objectives including resource allocation and budgeting process for regulatory activities.
• Enable and participate in the continuous dialogue, co-operation and planned resolution of major issues of concern with key regulators and other health authorities.
• Ensure appropriate advocacy strategies are in place to shape evolving legislation / requirements in partnership with relevant experts.

 Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree
• 5 or more years industry regulatory affairs experience
• 5 or more years leading matrixed teams across global regions

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• PhD or Masters’ degree in life sciences or pharmacy
• Strong technical knowledge required to be able to assess regulatory compliance of products
• Ability to interact with regulatory officials and support advocacy initiatives

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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