Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 18,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service. The company ranks among the top five generics companies in several markets around the world and is the largest U.S.-based generics manufacturer in the world. Through its India-based subsidiary Mylan Laboratories Limited, Mylan has direct access to one of the world’s largest active pharmaceutical ingredient (API) manufacturers. This relationship makes Mylan one of only two global generics companies with a comprehensive, vertically integrated supply chain. Mylan Laboratories Limited also is one of the world’s largest producers of API used to make generic antiretroviral (ARV) therapies for the treatment of HIV/AIDS. Additionally, Mylan operates a fully integrated specialty pharmaceutical business, Mylan Specialty (f/k/a Dey), which produces innovative medicinal therapies, including EpiPen® Auto-Injector.
Post Name : Senior Executive- Regulatory Affairs -injectable
Job Description-
– Responsible for dossier filing of Parenteral production for Regulated markets
– Preparation of eCTD (Module 3) for new product submissions adhering to the quality standards
– Preparation of renewal packages for injectable generic products
– Change control assessment and monitoring regulatory action plan affected by the changes and finalizing the variation strategy for Europe and US markets
– Review and provision of response to queries or complete response letters raised from various health agencies
– Reviewing regulatory documents (specifications, stability protocols, process validation reports, batch manufacturing records, packaging documents, stability data, etc.) for submission with the regulatory agencies in support of new ANDA submissions, renewals, variation and response to queries
– Candidates with Master in Pharmacy, working knowledge with injectable dosage forms will be an added preference
– Should have min 2 years experience
– Positions are open for both Bangalore and Hyderabad locations
Experience : 2 to 6 years in Pharma Industry R&D.
Educational Qualification : M.Pharma/ B.Pharma
Nationality :Indian
Job Location – Bengaluru(Marathahalli), Hyderabad(Gachibowli)
Contact Sheela Divekar
Mylan Laboratories Limited
Email – [email protected]
