Regulatory Affairs CMC (US Market) Aurobindo Pharma

6.0 - 10.0 years

6 - 14 Lacs

hyderabad

Work from Office

Role & responsibilities Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, and regulatory standards in response. Evaluation and good interpretation of post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines. Evaluate and interpret post-approval changes & Review of Pharmaceutical Development Reports, Review key regulatory documents such as specifications, process validation reports, hold time reports, stability protocols/data, Nitrosamine risk assessment reports, and technical packages. Formulate US regulatory filing strategy for new projects. Preparing quarterly and monthly targets. Allotting and evaluating targets of the team. Good interpretation skill for ICH and FDA guidelines

Posted 19 hours ago

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Regulatory Consultant (CMC/ EU Market Exp) Syneos Health

5.0 - 9.0 years

8 - 11 Lacs

hyderabad

Remote

Role & responsibilities Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions. Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies. Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle. Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems. Prepare estimates for conducting regulatory services as part of single or multiple service proposals. Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities. Ensure compliance with appropriate global regulatory requirements and the companys policies and processes. Prepare training materials and share best practices in the regulatory area, both internally and externally. Participate as regulatory support in internal or external project audits. Participate as regulatory support on internal cross-functional initiatives. Contribute to the creation and/or maintenance of SOPs and other process related documentation as required. Provide support in oversight to team members in the execution of their project responsibilities. Capable of identifying when to ensure line support required to provide additional guidance and direction. Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training. QUALIFICATION REQUIREMENTS Should have 5+ years total work experience and 4+ years relevant experience in Regulatory Affairs. Should have markets experience in EU (mandatory) , GCC (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates) , MEA MS, M.Pharm or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory. Moderate pharmaceutical/medical device related experience. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example post-approval CMC variations, IND, PMA, NDA, MAA, and CTD, including electronic submissions. Excellent interpersonal / communication skills including excellent written and verbal communication skills. Excellent customer service skills, with the ability to work both as a team member and independently. Good quality management skills. Advanced skills in Microsoft Office Applications. Strong experience in handling Veeva RIMS and TrackWise along with other RIMS systems, would be preferred. Ability to interact with staff from multiple departments and offices to establish project standards. Good initiative, adaptability, and pro-activity. Strong analytical skills, good attention to detail. Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Fluent in speaking, writing, and reading English.

Posted 5 days ago

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