Regulatory Affairs Manager for Injectable Medicines
7 days ago
Job Title: Regulatory Affairs Manager for Injectable Medicines
\About the Role: We are seeking a highly skilled Regulatory Affairs Manager to join our team in Ahmedabad, Gujarat, India. As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements and facilitating the approval process of new medicines.
\Key Responsibilities:
\- \
- Compile, prepare, review, and submit ANDA submissions and Amendments to FDA with an overall objective to avoid major deficiencies and contribute to getting approval within the shortest timeframes possible.\
- Maintain full awareness of all regulatory activities on assigned projects and ensure that project deadlines and performance standards for these projects are established and met.\
- Have expertise/prior experience in Sterile (Injectables/Ophthalmic) dosage form ANDAs.\
- Review/prepare documents which meet the requirement set forth by US FDA and accepted for review by FDA without query or RTR.\
- Evaluate change controls and formulate strategies for correct filing categories, with guidance from supervisor. Proactively raise major project issues if any to superior for resolution and agreement. Compile and submit critical post-approval supplements, such as CBE, CBE-30, and PAS as and when necessary.\
- Work very closely with all relevant departments at the time of product initiations, R&D phase, ANDA/Bio Execution, and after initiation of stability to ensure timely availability of all documents to ensure timely submissions.\
- Prepare and finalize controlled correspondence to FDA on specific issues as needed for assigned projects.\
- Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment, and discuss with superiors to finalize the strategy to respond to the deficiency.\
- Earn a competitive salary of approximately ₹12.5 lakhs per annum, depending on qualifications and experience.\
- Gain exposure to a dynamic work environment with opportunities for professional growth and development.\
- Benefit from a comprehensive benefits package, including medical insurance, retirement plans, and paid time off.\
- Foster a culture of innovation, teamwork, and open communication.\
- Demonstrate commitment to diversity, equity, and inclusion, promoting a workplace where everyone feels valued and respected.\
- Pursue your career goals in a supportive and collaborative environment.\
- Learn from experienced professionals and develop valuable skills in Regulatory Affairs.\
- Enjoy a healthy work-life balance, with flexible schedules and generous leave policies.\
- Stay up-to-date with industry trends and best practices through ongoing training and professional development opportunities.\
- Experience the excitement of working in a fast-paced, results-driven organization.\
- Engage in meaningful work that contributes to the betterment of society.\\/ul>\
About Us: Lifelancer is a talent-hiring platform connecting professionals with exciting opportunities in Life Sciences, Pharma, and IT. We foster a diverse and inclusive workplace culture, promoting equal opportunities and professional growth.
\Qualifications: M. Pharm
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