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Regulatory Affairs Executive Job in Mumbai – Concept Pharmaceuticals
Published on: September 20, 2026
Concept Pharmaceuticals Ltd has announced a Regulatory Affairs vacancy in Mumbai, Maharashtra, for professionals with experience in pharmaceutical regulatory submissions and compliance. The position is based at Andheri H.O., Mumbai, with an advertised salary starting from ₹40,000 per month.
The role covers regulatory dossier preparation, product registrations, regulatory submissions, post-approval activities and coordination with different pharmaceutical departments.
Important: The supplied vacancy uses both “Regulatory Affairs Executive” and “Regulatory Affairs Manager” as the designation. Candidates should confirm the exact job title and current vacancy status with the company before applying.
1. Concept Pharmaceuticals Regulatory Affairs Vacancy – Job Details
| Details | Information |
|---|---|
| Company | Concept Pharmaceuticals Ltd |
| Position | Regulatory Affairs Executive / Regulatory Affairs Manager |
| Location | Andheri H.O., Mumbai, Maharashtra |
| Job Type | Full-time |
| Work Location | In person |
| Salary | From ₹40,000 per month |
| Benefit | Provident Fund |
| Industry | Pharmaceutical |
| Application Email | hrd@conceptpharma.com |
| WhatsApp CV | 9870949809 |
| Online Application Form | Apply Through Google Form |
2. Eligibility & Experience
The vacancy is aimed at experienced Regulatory Affairs professionals, but the supplied listing does not mention a specific degree or minimum number of years of experience.
The work appears particularly relevant to candidates who have handled:
| Area | Relevant Experience |
|---|---|
| Regulatory submissions | ANDA, NDA, DMF and MA submissions |
| Dossiers | CTD/eCTD preparation and review |
| Product registration | Domestic and international registrations |
| Post-approval work | Variations, renewals, amendments and supplements |
| Regulatory communication | Queries, clarifications and agency responses |
| Compliance | Regulatory documentation and applicable guidelines |
If you are already working in pharmaceutical Regulatory Affairs, compare your actual experience with the responsibilities above rather than relying only on the job title.
For readers exploring similar opportunities, our Regulatory Affairs Jobs guide covers related pharmaceutical Regulatory Affairs roles.
3. What Does the Regulatory Affairs Role Involve?
This is a documentation-heavy role with a strong focus on regulatory submissions and product registrations.
The selected professional may work with regulatory documents, coordinate information from internal departments, communicate with regulatory authorities and keep submissions on track.
The vacancy also refers to both domestic and international regulatory activities, so familiarity with different regulatory markets can be useful.
4. Key Responsibilities
| Responsibility | What It Involves |
|---|---|
| Regulatory dossiers | Preparing and reviewing CTD/eCTD documentation |
| Product registration | Supporting pharmaceutical registrations in different markets |
| Regulatory submissions | Handling submissions such as ANDA, NDA, DMF and MA |
| Agency communication | Responding to regulatory queries and requests |
| Post-approval activities | Variations, renewals, amendments and supplements |
| Compliance | Following applicable regulatory requirements and updates |
| Documentation | Maintaining regulatory records and submission-related documents |
| Coordination | Working with R&D, QA, QC, Manufacturing and Marketing |
5. Regulatory Dossier Preparation
A major part of the role involves preparing and reviewing regulatory dossiers.
The vacancy mentions CTD and eCTD formats along with submission areas such as:
- ANDA
- NDA
- DMF
- MA
- Product registrations
Accuracy matters here because these dossiers bring together technical, quality and administrative information required by the relevant regulatory authority.
6. Product Registration and Regulatory Submissions
The position involves supporting product registrations and regulatory submissions for different markets.
The vacancy mentions regulatory agencies including:
- CDSCO
- USFDA
- EMA
- MHRA
- Other global regulatory authorities
Professionals with previous experience in registration procedures, regulatory documentation and submission management may find this part of the role particularly relevant.
For regulatory reference, applicants can consult the official websites of CDSCO, USFDA, EMA and MHRA.
7. Responding to Regulatory Queries
Regulatory submissions can lead to questions or requests for additional information from authorities.
The role includes responding to such regulatory queries and agency communications. This generally requires reviewing the question, collecting the necessary information from internal teams and preparing a clear response within the required timeline.
8. Working With Other Departments
Regulatory Affairs rarely works in isolation. The vacancy mentions coordination with several pharmaceutical functions.
| Department | Possible Regulatory Affairs Coordination |
|---|---|
| R&D | Technical and product information |
| Quality Assurance | Quality documentation and compliance |
| Quality Control | Testing and analytical information |
| Manufacturing | Manufacturing-related information |
| Marketing | Product and market-related requirements |
Good coordination is important when information has to be collected from several teams for a submission or regulatory response.
9. Post-Approval Regulatory Work
Regulatory responsibilities continue after a product receives approval.
The advertised role includes post-approval variations, renewals, amendments and supplements. These activities can involve updating regulatory documentation when approved products undergo changes or when regulatory submissions need to be renewed or amended.
10. Documentation and Compliance
The position also involves maintaining regulatory records and tracking submission-related activities.
Professionals in this area need to stay familiar with applicable regulatory requirements and keep documentation organized. Attention to detail is particularly useful when managing multiple products, markets and submission timelines.
11. Skills That Can Help
Based on the responsibilities in the vacancy, the following skills are relevant:
- CTD/eCTD dossier preparation
- Regulatory submission experience
- Product registration knowledge
- Regulatory documentation
- Understanding of pharmaceutical regulations
- Regulatory query handling
- Submission tracking
- Cross-functional coordination
- Good written communication
- Attention to detail
12. Salary and Benefits
The advertised salary starts from ₹40,000 per month. The vacancy also mentions Provident Fund as a benefit.
The final salary and employment terms may depend on the candidate’s experience, qualifications and the company’s hiring conditions. These details should be confirmed directly with the employer.
13. Job Location
The position is based at:
Andheri H.O., Mumbai, Maharashtra
The vacancy specifies an in-person work arrangement.
Candidates travelling for an interview or joining should confirm the exact office location and working schedule with the company beforehand.
14. How to Apply
Candidates interested in the Concept Pharmaceuticals Regulatory Affairs vacancy can submit their updated CV using the contact details below.
Email: hrd@conceptpharma.com
Email Subject: Application for Regulatory Affairs Executive
WhatsApp CV Submission: 9870949809
Candidates should highlight relevant Regulatory Affairs experience, particularly regulatory submissions, dossier preparation, product registration and post-approval activities, wherever applicable.
You can also visit the official Concept Pharmaceuticals website for company information or use the application form below.
Online Application Form: Apply Through Google Form
Before submitting your CV, confirm that the application form is active and relates to this vacancy.
15. Resume Tips for Regulatory Affairs Candidates
For this type of position, avoid sending a generic pharmaceutical CV.
Highlight specific experience such as:
- CTD/eCTD submissions
- ANDA/NDA/DMF/MA work
- Product registrations
- Regulatory authority correspondence
- Variations and renewals
- Regulatory databases or submission tracking
- Markets and agencies handled
Mentioning the specific regulatory markets and types of submissions you have worked on can make your experience easier for a recruiter to understand.
16. Common Mistakes to Avoid
Before applying, check a few basic things:
- Use the requested email subject.
- Mention relevant Regulatory Affairs experience clearly.
- Do not claim regulatory experience you do not have.
- Check the designation because the listing uses two different titles.
- Confirm whether the vacancy is still active.
- Confirm the eligibility requirements if your qualification or experience does not clearly match the listing.
17. Frequently Asked Questions
What is the salary for this Regulatory Affairs vacancy?
The advertised salary starts from ₹40,000 per month.
Where is the job located?
The position is based at Andheri H.O., Mumbai, Maharashtra.
Is this a full-time position?
Yes. The vacancy is listed as a full-time, in-person position.
Is a specific degree mentioned?
The supplied vacancy does not specify a particular educational qualification.
How much experience is required?
The listing asks for a qualified and experienced Regulatory Affairs professional, but does not state a specific minimum number of years.
Which submissions are mentioned?
The vacancy mentions ANDA, NDA, DMF, MA and product registration, along with CTD/eCTD dossier preparation.
Which regulatory authorities are mentioned?
The listing refers to CDSCO, USFDA, EMA, MHRA and other global regulatory authorities.
How can I apply?
Send your CV to hrd@conceptpharma.com with the subject “Application for Regulatory Affairs Executive.” The vacancy also provides 9870949809 for WhatsApp CV submission.
Is the designation Executive or Manager?
The supplied vacancy uses both Regulatory Affairs Executive and Regulatory Affairs Manager. Confirm the exact designation with the employer before applying.
18. Related Regulatory Affairs Opportunity
Explore more opportunities on our Regulatory Affairs Jobs page to find relevant openings in the pharmaceutical industry.
19. Important Note
The job information above is based on the supplied vacancy details. The listing does not clearly specify the required degree or minimum experience, and it uses two different designations.
PharmaCareerUpdates.com is an independent career-information website and is not affiliated with Concept Pharmaceuticals Ltd. Candidates should verify the current vacancy status, exact designation, eligibility, salary and application instructions with the employer before applying.
20. Final Thoughts
This Concept Pharmaceuticals vacancy covers several areas of Regulatory Affairs, including dossier preparation, product registration, regulatory submissions, agency communication and post-approval work.
For experienced Regulatory Affairs professionals, the most important step is to compare their actual submission and registration experience with the responsibilities in the vacancy. Since some eligibility details are not clearly stated, confirming those details with the company before applying is advisable.
