Website:
medsurgehc.com
Job details:
Role Description The Regulatory Affairs Executive role is a full-time, on-site position based in Bengaluru. This role involves preparing, reviewing, and maintaining regulatory dossiers and documentation in line with UK, UAE, Malaysia, Saudi requirements and company standards. The executive will coordinate submissions to regulatory authorities, track application statuses, and support approvals and renewals for existing and new products. Daily activities include monitoring regulatory changes, ensuring ongoing regulatory compliance, and collaborating with cross-functional teams such as quality, supply chain, and commercial to support product lifecycle management. The role also requires maintaining accurate records, preparing reports for internal stakeholders, and contributing to process improvements in the regulatory function.
·Technical Skills:
o Strong knowledge of regulatory strategy and submission requirements for orals and injectable dosage forms.
o Experience with regulatory submission management tools and document management systems.
o Proficiency in preparing regulatory documents, including briefing packages, submissions, and responses to regulatory queries.
o Experience supporting inspections, audits, due diligence activities, and partner evaluations.
Education:
o Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biology, Biochemistry, or a related field;
Experience:
o 4+ years of experience in Regulatory Affairs, with significant experience in oral solid dosage forms and injectables.
Extensive experience in regulatory affairs, CMC, and regulatory operations across UK/UAE/Malaysia/Saudi markets
Qualifications
o Experience in managing regulatory activities across UK/UAE/Malaysia/Saudi markets.
o In-depth knowledge of regulatory requirements for oral and injectable products, including clinical development considerations and lifecycle maintenance.
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