job description
Join GSK as a Senior CMC Regulatory Strategy Manager and play a pivotal role in shaping the regulatory landscape for our innovative healthcare solutions. Based in the vibrant regions of Bali, you will lead the development and execution of Chemistry, Manufacturing, and Controls (CMC) regulatory strategies to ensure compliance and accelerate product approvals. This is a unique opportunity to work in a dynamic environment while contributing to life-changing medical advancements.
As part of our global team, you will collaborate with cross-functional stakeholders to navigate complex regulatory requirements, drive strategic initiatives, and ensure the successful submission of high-quality regulatory dossiers. Your expertise will be instrumental in maintaining GSK's reputation as a leader in the healthcare industry.
If you are a strategic thinker with a passion for regulatory affairs and a desire to make a meaningful impact, we invite you to apply and become a key player in our mission to improve global health outcomes.
Responsibility
- Develop and implement CMC regulatory strategies for product development and lifecycle management.
- Lead the preparation and submission of regulatory dossiers, ensuring compliance with global health authority requirements.
- Collaborate with cross-functional teams, including R&D, Manufacturing, and Quality Assurance, to align regulatory strategies with business objectives.
- Provide expert guidance on CMC-related regulatory issues and risk assessments.
- Monitor and interpret evolving regulatory guidelines to ensure proactive compliance.
- Represent GSK in interactions with health authorities, including meetings and negotiations.
- Drive continuous improvement initiatives to enhance regulatory processes and efficiency.
- Mentor and develop junior team members to build a strong regulatory affairs capability.
Qualifications
- Bachelor's degree in Pharmacy, Chemistry, Biochemistry, or a related scientific field. Advanced degree preferred.
- Minimum of 8 years of experience in CMC regulatory affairs within the pharmaceutical or biotechnology industry.
- In-depth knowledge of global regulatory requirements, including ICH, FDA, EMA, and other health authority guidelines.
- Proven track record of successful regulatory submissions and interactions with health authorities.
- Strong analytical and problem-solving skills with the ability to interpret complex regulatory data.
- Excellent communication and interpersonal skills to effectively collaborate with internal and external stakeholders.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
- Experience in HIV or infectious disease therapeutics is a plus.