Job Description
We are seeking two seasoned Regulatory Affairs professionals at the Assistant Manager/Manager level for our International Markets division. Based in Mumbai, these full-time positions offer a critical role in global product registration, with one role focused on the ROW (Rest of World) markets and the other on the EU market. The successful candidates will ensure our pharmaceutical products comply with all international regulatory requirements.
• Your primary responsibility will be managing the end-to-end registration process for pharmaceutical products in your designated region (ROW/EU), from dossier preparation to approval.
• You will be an expert in preparing high-quality submission dossiers in ICH CTD, ACTD, and EU CTD formats, tailored to specific country requirements.
• A key part of the role involves acting as the key liaison, responding to complex queries from regulatory consultants and Ministry of Health (MOH) authorities in international markets.
• You will ensure strict adherence to ICH guidelines and all regional regulatory norms, leveraging your deep understanding of international compliance standards.
Skill Requirement
The ideal candidate is an expert in international pharmaceutical regulations with a proven track record in a leading company. You must possess exceptional attention to detail, outstanding communication skills, and the ability to manage complex submissions for diverse global markets.
• Mandatory Qualifications: A Master’s in Pharmacy (M.Pharm) or an MBA is required. You must have 5-6 years of hands-on regulatory affairs experience exclusively within a top 10 pharmaceutical manufacturing/export company.
• Regional Expertise: Demonstrated, specific experience with regulatory norms and dossier preparation for either ROW/PICs or EU markets is essential.
• Technical Proficiency: Must be well-versed in ICH guidelines and have a strong command of CTD, ACTD, and EU CTD dossier formats.
• Professional Skills: Excellent command of written and spoken English is mandatory for communication and dossier preparation. The role requires joining within one month.