Are you looking to advance your career in the pharmaceutical industry? If so, you may find the perfect opportunity at Adaptis Pharma, a prestigious name in the pharma sector. We are actively hiring for the position of Formulation Regulatory Affairs Assistant Manager in Pune, India. This role is ideal for professionals with a wealth of experience in regulatory affairs, particularly in the USA market.
About Adaptis Pharma
At Adaptis, we are dedicated to improving lives through innovation in pharmaceuticals. With a robust portfolio and a commitment to excellence, we seek to enhance patient outcomes worldwide. Our team is comprised of skilled professionals who strive for quality and integrity in every aspect of our work. If you are passionate about making a difference in the pharmaceutical landscape, we would love to hear from you!
Job Title: Formulation Regulatory Affairs Assistant Manager
Location: Pune, India (Work From Office)
Qualifications:
- Education: Master’s in Pharmacy (M. Pharm) or Bachelor’s in Pharmacy (B. Pharm)
- Experience: 4-6 years in Formulation Regulatory Affairs, specifically for the USA market
Key Responsibilities:
As a Formulation Regulatory Affairs Assistant Manager, your contributions will be pivotal to our team. Your tasks will include:
- Preparation of ANDA/NDA: You will be responsible for preparing Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA) for Solid Orals and Injectables. This includes a thorough understanding of the regulations governing these submissions.
- Section Writing: Writing and organizing the necessary sections of the Common Technical Document (CTD) format M1, M2, M3, and M5. Your expertise will ensure that all submissions are compliant with regulatory standards.
- Document Review: You will review Chemistry, Manufacturing, and Controls (CMC) documents, labelling, and bioequivalence documents to ensure all information meets the regulatory requirements for submission.
- eCTD Compilation: You will be involved in the electronic Common Technical Document (eCTD) compilation, which is crucial for seamless submission processes.
- ANDA Review: Analyzing and reviewing Original ANDA submissions will be part of your responsibilities to safeguard the quality of our applications.
- Query Response Drafting: During the ANDA review cycle, you will draft responses to queries raised by regulatory bodies, ensuring timely and accurate communication.
- Post Approval Supplements Support: Support the team in preparing and managing post-approval supplements, ensuring compliance with evolving regulations.
Why Join Adaptis Pharma?
Joining Adaptis Pharma means being part of a team that values innovation and collaboration. You will be positioned to grow your career within a supportive environment, where your expertise is recognized and nurtured. Additionally, you will have the opportunity to work closely with experienced professionals who are dedicated to improving pharmaceutical standards.
How to Apply
If you believe you meet the qualifications and are excited about this opportunity, we encourage you to submit your application. To learn more about the role or to apply, please contact us at info@adaptisls.com. We look forward to your application!
