Manasa Ks
Regulatory Affairs Specialist @ProductLife Group
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WORK HISTORY
Regulatory Affairs Specialist @ProductLife Group
Ahmedabad, IN
Managed lifecycle submissions, including CMC variations, safety variations, PSURs, and renewals.2. Tracked document availability, submission, and approval statuses for compliance.3. Coordinated system updates (LSRIMS, Power BI, ERECA, CHPH) with local affiliates.4. Ensured availability of M3 ToC documents and supported Publishing KoMs.5. Provided updates to GRT and resolved pending submission issues.6. Prepared global PSUR and renewal plans for cardiovascular, NiTA, and diabetes products.7. Assisted in creating SODA tickets for publishing
EDUCATION
Dayananda Sagar Institutions
Doctor of Pharmacy - PharmD
ABOUT MANASA KS
Regulatory affairs professional with 5 years of experience managing global regulatory submissions for CTAs, lifecycle submissions, and compliance in therapeutic areas like cardiovascular, NiTA, and diabetes. Skilled in dossier preparation, strategic guidance, and ensuring timely approvals by collaborating with cross-functional teams and regulatory authorities. Experienced in mentoring teams, providing technical advice, and supporting business development through project planning and budgeting. Proven ability to track submissions, maintain compliance, and drive regulatory strategy for successful outcomes.
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