At Strides, the truly global pharma company, each day is more exciting – you never know from which part of the world the challenge may come! In just 16 years, we have become a Rs.750 Crore top 15 pharmaceutical company. Behind our extra-ordinary international strides lies the will to excel which is reflected in our Global vision of partnering with over 10 of the top 50 pharmaceutical majors worldwide. We operate in the regulated markets like USA, Europe, Australia, New Zealand, South Africa, Japan and in several other emerging markets across the Globe. We are also in the forefront in the global fight against AIDS, TB & Malaria worldwide. We have 14 world class manufacturing facilities spread across India, USA, Europe, Brazil, Mexico, Poland & Singapore. As we surge forward, we seek professionals for our plants in Bangalore, perfectionists, who seek to rise above even global expectations.
Job Title – Executive Sr.executive Regulatory Affairs ANDA
Experience – 2 – 6 yrs
Location – Bengaluru
Salary : INR 3,00,000 – 7,50,000 P.A.
1. To collate and compile the dossiers and deficiencies responses as per USFDA regulatory requirements for US market.
2. Review and approval of documents required for compilation of ANDAs and deficiencies responses purpose.
3. Uploading and formalization of ANDA in eCTD format using eCTD dossier management software.
4. Co-ordinate with various cross functional team members for collecting the documents required for compilation of ANDA and responding to USFDA/Customer deficiencies and other applicable submissions as the case may be.
5. To assist regulatory supervisor/ head in formulizing various regulatory documents as required for formalizing regulatory strategy for various submissions.
6. Compiling and filing responses for FDA raised deficiencies with the support of immediate supervisor/head.
7. Preparation of USDA letters and coordinating for submission.
8. Reviewing Product Development Plans, Reports and other required documents as a part of regulatory filing for US market.
9. Assist for product Life Cycle Management and Supplements for US market as the case may be.
- UG – Pharma