Raghu P

Regulatory affairs Specialist

Role: Regulatory Affairs Officer at Bioplus Life Sciences
Location: Bengaluru, KA, IN
LinkedIn followers: 500 followers

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Experience

Regulatory Affairs Officer
Bioplus Life Sciences
Dec 2023 — Present · Bengaluru, IN
As a Regulatory Affairs officer at BioPlus Life Sciences I am responsible for preparation and submission of product dossier, renewals and variations for Global markets. I also collaborate with cross-functional teams to ensure compliance with regulatory standards and requirements, to address queries from authorities.Contributed to IND, NDA,submissions for EU and TGA markets with a focus on accuracy,

Education

JSS College of Pharmacy - mysuru
Postgraduate , pharmaceutical Quality assurence
Sree Siddaganga College of Pharmacy
Bachelor of Pharmacy
JSS Co.
Bachelor of Pharmacy, Quality Assurance

Contact information

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Work email
•••••@bioplus.in
Personal email
•••••@•••••.com
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Current company

Bioplus Life Sciences

Pharmaceutical Manufacturing · 531 employees · Founded 2004 · Bangalore, Karnataka, India

Bioplus, Pioneering life-saving science for a healthier future Bioplus Life Sciences is a leading biopharmaceutical company with over 75 years of experience serving the pharmaceutical industry. Building on a strong foundation of high-quality products, services, and technology in contract manufacturing and generic pharmaceuticals, Bioplus today is a late-stage clinical phase company focused on developing novel therapeutics to address significant global unmet needs. The company has two clinical phase-3 ready programs and a rich pipeline of pre-clinical candidates, targeting global blockbuster potential. Additionally, we maintain a robust pipeline of pre-clinical programs, positioning us for significant growth over the next five years as our groundbreaking novel therapeutics enter the market. Bioplus intends to partner with leading regional and global companies to optimize product market access. Notably, it is the only company in India to have successfully commercialized microalgal fermentation for Omega-3 fatty acids. A pioneer in advanced fermentation biotechnology, Bioplus holds over 40 patents and possesses more than 15 years of expertise. Complementing this expertise, Bioplus operates a state-of-the-art synthetic biology lab dedicated to the development of innovative recombinant proteins, peptides, and pharmaceutical ingredients. With over 14 drug candidates in development and established partnerships with leading universities across India, the USA, and Europe, Bioplus remains committed to cutting-edge research and development. The company is significantly investing in R&D, clinical development, and CAPEX for capacity and capability expansion, anticipating significant growth over the next 5 years as its novel therapeutics reach the market. Bioplus is driven by scientific curiosity, focused on targeted clinical development, and dedicated to contributing to the health and well-being of global citizens. Innovate, Explore, Develop

bioplus.in

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Experience

Regulatory Affairs Officer

Education

JSS College of Pharmacy - mysuru

Sree Siddaganga College of Pharmacy

JSS Co.

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