Bajrang Khalde

Senior Regulatory Affairs Executive with 7 years in Human & Veterinary pharmaceuticals. Proven expertise in CTD (Module 1-5) ACTD, Country specific submissions for CDSCO, GCC, ROW markets. Handled 25+ new registrations & 40+ variations including Solid dosage form, injectables and feed additives. Skilled in CDSCO Sugam applications - Form 44, Form 11, Export NOC and direct liaison with health authorities. Seeking RA Specialist roles.

Sr. Executive Drug Regulatory Affairs - VEKO CARE PVT. LTD. - Pune

(2024-11)

• Maintain overall Product registration Lifecycle Management.
• To ensure compilation, review and submission of registration dossiers as per the country specific requirement, in ACTD and CTD formats.
• To maintain close and effective coordination with cross functional team and various manufacturing sites for preparation of compliant Product dossiers.
• Keeping track of Registration, renewal status of the company.
• Submission of dossiers and follow-up closely with MOH /Country clients.
• Ensuring effective and timely attention and handling of queries responses with Ministry of Health (MOH) of various countries.
• Ensuring timely communication with respective countries for registration, renewal, variation and plant inspections.
• Due diligence dossier and gap assessment of the drug product.
• Supervision to prepare and submit applications for CDSCO Export NOC, Form – 44 NDA, Form 11 Import Licence, Product license, COPP, FSC, WHO-GMP certificate and all Tender related applications with various locations and manufacturing sites and follow up directly or through Manufacturer/Agents.
• To prepare and submission Dossier for Nutraceutical products.
• Artwork development, Reviewing and Approvals for Pharmaceutical products as per country guidelines and Nutraceutical products as per India FSSAI guidelines.
• To search and finalize Brand Names and co-ordinate with Trademark agent to getting approval from Trademark Registry.
• Review of CMC and labeling Documents.
• Review of quality documents such as process validation protocol, stability protocol, specification, DMFs, PDR etc.
• Review dossiers for Third party and Contract manufactures and submission to MoH.
• Variation and Post approval Changes submission to regulatory authority as per regulatory guidelines.
• Coordinate administrative tasks such as ordering legalization, CPP to facilitate submissions.
• Change control evaluation and approval.

Assistant Manager - Drug Regulatory Affairs - DELTA BIOPHARMA PVT. LTD. - Mumbai

(2022-07 - 2024-10)

Drug Regulatory Affairs Officer - KAMLA LIFESCIENCES LTD. - Tarapur Mumbai

(2021-02 - 2022-06)

Regulatory Affairs Officer - V.S. INTERNATIONAL PVT. LTD. - Daman India

(2019-04 - 2021-02)

M.Sc. - Dr. D. Y. Patil University (2020)

B.Sc. - Pune University (2018)

H.S.C. - Pune Board (2014)

S.S.C - Pune Board (2012)