07/10/2026 updated
100 % available
Senior Manager Regulatory Affairs - Pharmaceutical Industry (Europe & UK)
Vadodara, India
Only remote
M.Pharm - Department of Pharmaceutical Sciences, Nagpur University (2005)About me
With 20 years experience, I have led regulatory strategy development and execution of projects for Europe and the UK submissions. My expertise spans CMC, eCTD dossier compilation, and managing post-approval variations, Scientific Advice and query response preparation.
ComplianceMedication Administration RecordsProduct Lifecycle ManagementMedicines and Healthcare Products Regulatory Agency (MHRA) GuidesRegulatory Affairs
Regulatory Strategy & Dossier Submissions
Expertise in building and executing regulatory strategies for Europe/UK markets, including timely dossier submissions for over 40 formulations. Proficiency in handling National, MRP and DCP submission types as well as eCTD compilation using tools like PharmaReady and Veeva-vault.
CMC Dossier Management
Proficiency in handling Chemistry, Manufacturing and Controls (CMC) dossier sections, including compilation of CTD Modules 1, 2 and 3 for various formulation types such as solid orals, liquid orals, parenteral/sterile preparations and buccal films.
Post-Approval Variations & Lifecycle Management
Proven track record in managing post-approval variations (Type IA/IAIN/IB/II), MA transfers, Article 61.3 submissions, and product lifecycle management throughout the entire product development cycle.
Scientific Advice & Pre-Submission Meetings
Building and submission of scientific advice and pre-submission meeting packages to regulatory agencies, including attendance at face-to-face and virtual meetings with regulatory authorities to present company strategy.
Query Response Management
Evaluation, planning, execution and preparation of scientific rationales and query responses for validation and technical phases received from different EU agencies for EU procedures.
Regulatory Compliance & Health Authority Relations
Adept at navigating regulatory landscapes, ensuring successful product approvals and maintaining robust relationships with health authorities across Europe and UK markets.
Cross-Functional Team Leadership
Proven track record in guiding cross-functional teams across different manufacturing sites, managing regulatory projects and driving product lifecycle management while mentoring colleagues and team members.
EU Submission Portals
Hands-on experience submitting via CESP, MHRA portal, Portugal national portal (SMUH-Alter), Austria National portal (AGES eServices) and Eudralink.
Due Diligence & Gap Analysis
Conducting due diligence and gap findings for dossiers of different formulation types including oral, parenteral, films and cream, ensuring regulatory compliance and readiness for submission.
Regulatory Strategy for Legal Basis Evaluation
Developing and implementing regulatory strategies for known active substances under different legal bases (10.1, 10.3, 10b, 10a etc.) as per EU directives 2001/83/EC, including evaluation for 8(3) mixed applications, line extensions and PUMA.
Experience
Professional experience10+ years
Freelancer since2026
Languages
EnglishFluent
Project history
Developing and implementing regulatory strategies for known active substances with different formulations for Europe/UK market. Building and submission of scientific advice/pre-submission meeting packages. Query response preparation for EU procedures. Compilation of CTD modules 1, 2 and 3 for tablet, oral solution, parenteral and film formulations. Managing post-approval variations (Type IA/IAIN/IB/II), MA transfers and Article 61.3 submissions. eCTD compilation using PharmaReady and Veeva-vault. Submissions via CESP, MHRA portal, Portugal national portal, Austria National portal and Eudralink. Co-ordination with internal/external stakeholders (CMO/CRO).
Compilation of CTD module 1 and submissions of National, DCP and MRP dossiers as well as query responses. Review of dossiers from various clients and co-ordination to resolve issues. Communications with Agency for DCP slots, getting PL number, variation change code confirmation. Submission of duplicate procedure, Renewal, Sunset clause extensions, MA transfers, Article 61.3 submission, withdrawals and variations for Type IA, Type IB, Type II.
Compilation of CTD Module 2 & 3 for Finished Drug Products. Preparation of quality query responses. Evaluation of change control requests with respect to regulatory impact for EU market.