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DDReg Pharma
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Assistant Manager Regulatory Affairs

Assistant Manager Regulatory Affairs

DDReg Pharma

4 - 8 years

0 Lacs

haryana

Posted:6 days ago| Platform: Shine logo

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Skills Required

regulatory affairs regulatory submissions gap analysis remediation renewals data analysis negotiation communication excel outlook powerpoint word presentation skills analytical skills cmc documentation lifecycle management regulatory strategies marketing authorization applications ctd dossiers variations interpretation of regulatory documentation drafting reviewing documents document management systems reporting skills regulatory logic global project coordination

Work Mode

On-site

Job Type

Full Time

Job Description

As an Assistant Manager Regulatory Affairs for EU & UK markets, your role involves driving CMC documentation, regulatory submissions, and lifecycle management to ensure compliance with regional and international guidelines. Your key responsibilities will include: - Conducting comprehensive CMC reviews of technical documentation for regulatory filings in 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. - 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. - Maintaining high-level knowledge of current country-specific regulations and tracking regulatory updates through respective health authority websites. Qualifications required for this role include: - Masters degree in Pharmacy or equivalent qualification. - 4 to 6 years of relevant experience in Regulatory Affairs, with a focus on EU and/or UK submissions. - Strong technical skills in data analysis, interpretation of regulatory documentation, and proficiency in document management systems and tools. If you join us, you will be part of a high-performing regulatory team that plays a critical role in bringing impactful pharmaceutical products to patients globally. You will work in a collaborative, fast-paced environment where your expertise shapes international market access strategies.,

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Assistant Manager Regulatory Affairs