Assistant Manager Regulatory Affairs DDReg Pharma

4.0 - 8.0 years

0 Lacs

haryana

On-site

You are a proactive and detail-oriented Assistant Manager in Regulatory Affairs (EU & UK) with a Masters Degree in Pharmacy (M.Pharm or equivalent) having 4 to 6 years of experience. You will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines. Your key responsibilities will include conducting comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets, performing Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards, developing and implementing regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications, preparing and compiling new CTD dossiers, variations, and renewals ensuring full compliance with applicable EMA/MHRA regulatory requirements and internal quality standards, critically reviewing documentation to ensure internal consistency, compliance with regulatory expectations, and support regulatory excellence, collaborating with cross-functional teams including R&D, QA, QC, Manufacturing, and external stakeholders for timely and accurate data collation and submissions, ensuring effective and efficient communication across teams to facilitate streamlined project execution and meet submission timelines, and maintaining high-level knowledge of current country-specific regulations, keeping track of regulatory updates through respective health authority websites (e.g., EMA, MHRA). You must possess strong technical skills in data analysis and interpretation of regulatory documentation, excellent interpersonal and problem-solving skills with a proactive and solution-oriented approach, effective negotiation and communication skills for liaising with internal teams and external agencies, proficiency in drafting and reviewing documents in line with global, regional, and national regulatory standards, expertise in document management systems and tools like Excel, Outlook, PowerPoint, and Word, strong presentation and reporting skills with the ability to explain complex regulatory concepts clearly, demonstrated ability to analyze data systematically, apply regulatory logic, and compile well-organized submissions, collaborative, results-driven, and self-motivated with the flexibility to adapt to shifting priorities, and capable of delivering high-quality outputs under pressure and within aggressive timelines. You should also have the flexibility to work in cross-time-zone schedules, as needed to support global project coordination or agency interactions. Joining this high-performing regulatory team will allow you to play a critical role in bringing impactful pharmaceutical products to patients globally in a collaborative, fast-paced environment where your expertise shapes international market access strategies.,

Posted 1 month ago

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Manager Regulatory Affairs EM DDReg Pharma Pvt. Ltd.

7.0 - 11.0 years

0 Lacs

haryana

On-site

You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Your tasks will include reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. It is essential to critically review documentation intended for submission to regulatory agencies to ensure internal consistency and adherence to relevant guidelines, thereby promoting regulatory excellence. You will be expected to demonstrate expertise in the subject matter and relevant areas, collaborate effectively with internal and external clients, and facilitate clear and efficient communication for operational excellence. A high level of knowledge regarding country regulations and regulatory guidelines, as updated from time to time on various agencies" websites, is also required. To qualify for this position, you must hold a Master's degree in Pharma and possess relevant experience equivalent to 7 to 10 years. Strong technical data interpretation skills, interpersonal skills, oral and written communication skills, and knowledge of US Regulations are essential requirements. Proficiency in using computer applications such as Excel, Outlook, and document management systems is necessary. Additionally, the ability to work effectively in a team-oriented environment, under pressure, and within tight timelines is crucial for this role. As part of the role, you may be required to work in slots catering to different time zones as needed. The position is based in Gurgaon, Haryana, India. Join us and contribute to our global regulatory team as an Assistant Manager in Regulatory Affairs, focusing on the US market and beyond.,

Posted 2 months ago

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