Current: English
Strides is inviting applications from qualified and experienced professionals for the positions of Executive and Senior Executive – Regulatory Affairs in Bengaluru, Karnataka. The opportunity is suitable for candidates with an M.Pharm qualification and 2–6 years of experience in regulatory affairs, particularly those with knowledge of regulatory submissions for European and UK markets.
Selected candidates will be responsible for regulatory documentation, Common Technical Document (CTD) preparation, electronic Common Technical Document (eCTD) submissions, and lifecycle management activities for pharmaceutical products.
Job Details
Company Name: StridesJob Title: Executive / Senior Executive – Regulatory AffairsDepartment: Regulatory Affairs (Europe & UK Market)Job Location: Bengaluru, Karnataka, IndiaQualification: M.PharmExperience: 2–6 YearsIndustry: Pharmaceutical IndustryApplication Email: sivashankar.mohanty@pivotpath.com
Educational Qualification and Experience
Candidates should have an M.Pharm qualification and 2–6 years of relevant experience in regulatory affairs within the pharmaceutical industry.
Applicants with experience in European and UK regulatory submissions, CMC documentation, CTD dossier preparation, eCTD publishing, and post-approval lifecycle management will find this opportunity relevant to their professional background.
Key Responsibilities
The selected candidates will be responsible for the following activities:
Regulatory Documentation: Compile regulatory documents and support the team in preparing submissions according to European and UK regulatory requirements, particularly for Chemistry, Manufacturing and Controls (CMC) and product labelling.
CTD Dossier Preparation: Compile and prepare new applications and lifecycle management CTD dossier modules from Module 1 (M1) to Module 5 (M5) for European and UK markets, as applicable to the submission.
Regulatory Deficiency Responses: Interpret regulatory queries and prepare responses to quality-related and administrative deficiencies within the specified timelines.
CMC Regulatory Strategy: Develop and implement regulatory CMC strategies to support new Marketing Authorisation Applications (MAAs), Post-Approval Changes (PACs), variations, and product lifecycle activities.
Cross-Functional Coordination: Coordinate with cross-functional teams to request, review, and collect documents required for regulatory submissions.
eCTD Publishing: Upload and publish regulatory documents using electronic Common Technical Document (eCTD) software for regulatory submissions.
Training Coordination: Arrange and coordinate training activities within the relevant departments.
Document Review: Critically review regulatory documentation intended for submission to ensure accuracy, completeness, and internal consistency.
Required Technical Knowledge
Candidates applying for this position should ideally have knowledge of the following areas:
European and UK pharmaceutical regulatory requirements.
Common Technical Document (CTD) structure and dossier preparation.
Electronic Common Technical Document (eCTD) publishing.
Chemistry, Manufacturing and Controls (CMC) documentation.
Marketing Authorisation Applications (MAAs).
Post-Approval Changes (PACs) and regulatory variations.
Regulatory deficiency responses and lifecycle management.
Pharmaceutical labelling requirements and document quality review.
How to Apply
Interested and eligible candidates can share their updated CV or professional profile through the following email address:
Email: sivashankar.mohanty@pivotpath.com
Subject Line: Application for Executive / Senior Executive – Regulatory Affairs
Candidates should ensure that their CV clearly highlights their educational qualifications, relevant regulatory affairs experience, technical skills, and exposure to European and UK regulatory submissions.
Note: This recruitment information has been prepared from the supplied hiring notice. Candidates should verify the vacancy details and application process with the recruitment contact before sharing personal information.
Frequently Asked Questions (FAQs)
1. What qualifications are required for the Strides Regulatory Affairs recruitment?
Candidates should have an M.Pharm qualification. The advertised experience requirement is 2–6 years in a relevant field.
2. What is the role of CTD dossier preparation in pharmaceutical regulatory affairs?
The Common Technical Document (CTD) provides a standardised structure for submitting pharmaceutical product information to regulatory authorities. It includes administrative information, summaries, quality documentation, nonclinical study reports, and clinical study reports. Regulatory professionals compile and review the relevant modules to support product registration and lifecycle management.
3. What is the difference between CTD and eCTD?
CTD refers to the Common Technical Document structure used to organise regulatory submission information. eCTD, or electronic Common Technical Document, is the electronic format used to submit and manage regulatory dossiers. It supports structured document publishing, lifecycle tracking, and electronic submission to regulatory authorities.
4. What are CMC, MAA, and post-approval changes in regulatory affairs?
CMC stands for Chemistry, Manufacturing and Controls and covers information about a pharmaceutical product’s composition, manufacturing processes, specifications, and quality controls. MAA stands for Marketing Authorisation Application, which is submitted to obtain permission to market a medicinal product. Post-approval changes are changes made after authorisation that may require regulatory assessment, notification, or approval, depending on the applicable regulations.
5. What technical skills are important for a Regulatory Affairs Executive working with European and UK markets?
Important skills include CTD dossier compilation, eCTD publishing, CMC documentation, regulatory requirements interpretation, product labelling review, preparation of responses to regulatory deficiencies, and lifecycle management. Candidates should also demonstrate strong documentation, communication, coordination, and deadline-management skills.
Strides Hiring for Executive / Senior Executive – Regulatory Affairs | Bengaluru
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