Assistant Manager - Regulatory Affairs IMPRONICS DIGITECH PRIVATE LIMITED

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

The ideal candidate for this role should possess a minimum education qualification of M. Pharmacy. You will be responsible for handling regulatory activities such as CTD dossier preparation, query resolution, and ensuring compliance with ICH guidelines and current regulatory standards. Your primary market focus will be on the Africa market, specifically in regions like Zazibona, South Africa, East Africa (Kenya, Tanzania, Ethiopia, etc.), and FWA. Your key responsibilities will include: - Preparation and submission of new dossiers - Conducting gap analysis of dossiers for completeness - Compiling dossiers in eCTD format for submission to various regulatory authorities - Coordinating dossier submissions in different countries - Evaluating and responding to queries, including coordination with manufacturers and final compilation of responses - Managing post-approval activities such as product lifecycle management, variations, and renewals - Monitoring harmonization of dossiers, queries, and variations across all countries - Developing artworks and obtaining approvals as per standard operating procedures - Engaging in daily communication with internal departments and external stakeholders - Updating trackers for queries and variations regularly - Attending unit and regional meetings, trainings, and other relevant sessions as required by the line manager and Intellectus Campus. Your role will require strong technical expertise in regulatory affairs, excellent communication skills, attention to detail, and the ability to manage multiple tasks while ensuring deadlines are met. Your proactive approach to problem-solving and ability to collaborate with various stakeholders will be crucial for success in this position.,

Posted 1 month ago

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Manager - Regulatory CMC SUN PHARMA

5.0 - 10.0 years

0 Lacs

haryana

On-site

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as delivering all regulatory milestones for higher complexity products. You will also be accountable for leading the development and review of the CMC Regulatory Strategy Document for projects of increasing complexity. In addition, you will be required to support new technology development within the company and demonstrate an unwavering focus on compliance in all activities. Your technical skills should include expertise in the preparation and review of dossiers, response to queries, and communication with agencies for markets like the US and EU. Furthermore, you should have proven experience in critically reviewing scientific information and possess superior oral and written communication skills in multicultural settings. The ideal candidate for this role will have demonstrated leadership skills, including the ability to generate innovative solutions to complex regulatory problems and effectively work with key stakeholders. You should also exhibit flexibility in responding to changing priorities and possess effective leadership, communication, interpersonal, and negotiating skills. Additionally, you should have good inter-personal skills with the ability to direct multi-departmental functions. This role requires a seasoned professional who is proficient in English, with additional language skills considered a plus. A minimum educational requirement of M-Pharm in pharmaceutical sciences is essential for this position. Lastly, you may be required to manage or mentor junior team members as part of your responsibilities.,

Posted 1 month ago

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