Site Regulatory Compliance Head

Job Purpose

The Site Regulatory Compliance Head at GSK is responsible for ensuring that all company operations, products, and processes comply with relevant regulatory requirements. The role involves developing, implementing, and managing regulatory compliance programs and procedures to ensure adherence to laws, regulations, and guidelines set by regulatory bodies. The Regulatory Compliance Manager will play a critical role in maintaining the company's reputation and protecting it from GMP and regulatory compliance risks. The role ensures the risks are identified, escalated and mitigation plans In-place. This position ensures that all critical Quality Regulatory Compliance activities at the site comply with applicable regulatory authority guidelines, QMS requirements, cGMP standards, and applicable local standard operating procedures.

Education, Experience & Skills

• Minimum 8 years of Experience in Quality Assurance, Regulatory Compliance, Quality Control, Validation, or a related field, including a position of significant responsibility.
• Bachelors, master's degree, Pharm D, Science Graduate.
• Strong knowledge of QMS, GMP and Regulatory requirements and guidelines.
• Good Knowledge of Regulatory environment of Pakistan.
• Proficient analytical, problem-solving, and decision-making skills.
• Strong communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders.
• Strongly developed communication skills both written and verbal.
• Strong organizational skills and ability to manage multiple priorities. Highly results oriented; ability to deliver and overcome obstacles.

Key Responsibilities

• Manage Quality Regulatory Compliance and systems on site by creating and executing regulatory compliance strategies and programs.
• Ensure to monitor changes in global and local regulatory environment/regulatory requirements and ensure GSK processes and products comply with applicable laws and regulations.
• Establish, review, and update site procedures to align with regulatory requirements.
• Accountable for timely communication, correspondence with Regulators, government officials for warrantors, queries, cases and any other correspondence in liaison with GSK Site team, GSK Legal and GSK Regulatory team.
• Responsible for attending meetings and hearings with government officials and regulators in liaison with Site Quality Head.
• Proactive engagement with regulator, where possible e.g. DTL, PQCB to expedite the current ongoing regulatory queries.
• Investigate and resolve compliance issues, including conducting root cause analysis and implementing corrective actions.
• Identify Internal and external risks associated with GSK, where applicable develop risk mitigation plan and monitor the implementation plan.
• Governance of regulatory KPIs and processes and identify and assess compliance risks to develop effective mitigation strategies.
• Engage and communicate effectively with internal stakeholders, senior management to ensure alignment on compliance matters.
• Ensure compliance of the site-specific regulatory SOP for "Management of Regulatory authority letters notifications and statutory regulatory orders (SRO) received at GSK Pakistan."
• Ensure the Inspection readiness at Site, escalates any issues which impacting inspection readiness to site senior management.
• Represent the site during regulatory inspections in coordination with site relevant team.
• Develop and maintain accurate records of site product registration details, regulatory submissions and correspondence with regulatory agencies.
• Ensures compliance with QMS Implementation on site to comply with the requirements of the GSK QMS, GSK internal policies, Global SOPs, and all related regulatory guidelines.
• Engages with the site to promote a culture of awareness and understanding of regulatory compliance.
• Provide training to employees on regulatory compliance topics to enhance their understanding and adherence to applicable regulations.
• Ensure to maintain accurate and up-to-date records of regulatory activities, decisions, and communications.
• Ensure reporting of compliance risks and issues to Site Quality Head, Site Director and at governance forum i.e. Site Quality Council, Site Leadership Team meetings.
• Permanent member of Site Quality Council and Risk Management Council Board meetings.
• The role may require traveling to attend regulatory meetings, conferences, visits or inspections.

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.

Contact information:

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