Masters Degree in Chemical Sciences With 2 years research experience in organic synthesis OR Masters Degree in Pharmaceutical Sciences With 2 years research experience in organic synthesis
B.Pharm and M.Pharm in the relevant specialization with first class or equivalent in any one of the two degrees. Possess the basic knowledge of Computer Application as prescribed by the Government of Gujarat.
Hetero Drugs is an Indian pharmaceutical company and the worlds largest producer of anti-retroviral drugs. Heteros business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.
Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. Today, Intas is present in more than 85 countries worldwide and is growing at 20% CAGR. Around 70% of its revenues come from the international markets, particularly the highly regulated markets of EU and US. At Intas, every day and everyone works to create a world of good health, happiness and hope.
M.Pharm with 15 to 20 years of experience in Formulation development of sterile, non-sterile Dosage forms as per guidelines of US, EU, Canada, Brazil and ROW market. Literature search, Pre - formulation and compatibility studies,formulation & development as per QbD, Scale-up and Technology transfer.
Craft and maintain BPCRs and SOPs with precision, Lead documentation management using EDMS to uphold data integrity and compliance, Drive training and compliance efforts through our LMS, Ensure all production documentation aligns with regulatory standards and internal policies.
Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article. Demonstrates understanding of client’s drugs labels and uses that knowledge effectively when performing the safety assessments.
Thorough knowledge of EU, MENA and ASEAN markets country requirements, regulatory affairs procedures for initial submission, licensing, post-approval submission management