Rameshwar Bhavale
Regulatory Affairs | CMC | eCTD
- Role
- Regulatory Affairs Associate at Emcure Pharmaceuticals Limited
- Location
- Pune, IN
- LinkedIn followers
- 500 followers
About Rameshwar Bhavale
Regulatory affairs professional having 2+ years of experience in handling of end to end regulatory submissions for regulated markets. Proficient in compilation of CMC modules for oral solids and injectable products. Review and analysis of quality documents to ensure compliance with regulatory guidelines. Responding to queries/deficiencies, labelling updates and lifecycle management activities. Hands on experience on Lorenz DocuBridge for eCTD publishing of ANDA, SANDA submissions and Post approval changes. Technical Skills: ANDA, SANDA, CMC, Post Approval Changes, Lifecycle Management, Queries, eCTD, Publishing, Annual Reports. Soft Skills: Problem-solving, Written and verbal communication, Collaboration and Teamwork, Interpersonal and networking, Project Management, Attention to detail and result oriented skills.
Experience
Regulatory Affairs Associate
Emcure Pharmaceuticals Limited
Oct 2022 — Present · Pune, IN
Education
Dr. Babasaheb Ambedkar Marathwada University, Aurangabad
Bachelor of Pharmacy
2016 — 2020
National Institute of Pharmaceutical Education and Research - Ahmedabad
Master of Science - MS
2020 — 2022
Deogiri College Aurangabad
Higher Secondary
2014 — 2016
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