Regulatory Affairs Executive job description
A regulatory affairs executive in pharma prepares, files and tracks the product dossiers and licence documents that a company needs to make and sell its medicines in India and in export markets.
Why the role exists
The role exists because a product cannot be made or marketed without the right approvals and up-to-date documents. In an Indian pharma firm the executive sits with the regulatory head, gathers data from quality, production and R&D, and handles queries from authorities and partners.
What the person does
- Compile product dossiers and applications from data supplied by R&D, quality control, quality assurance and production.
- Track the status of each submission and licence renewal on a tracker and chase pending items with internal teams.
- Review artwork, labels, leaflets and pack inserts against the approved product information before they go to print.
- Respond to queries from authorities and export partners with the right data, within the time agreed with the regulatory head.
- Maintain the regulatory file for each product, including approvals, variations and correspondence, in an orderly system.
- Check change controls raised by the plant to decide whether a change needs to be notified or approved before it is made.
- Follow circulars and guidance from authorities and share relevant changes with quality, production and marketing.
- Support inspections and customer audits by keeping the regulatory records ready and answering questions on them.
Skills and tools
- Preparing dossiers in common technical document style for domestic and export submissions
- Understanding of product composition, specifications, stability and manufacturing flow
- Document control and version tracking across many product files
- Precise written English for queries, cover letters and summaries
- Use of submission portals and electronic file formats used in regulated markets
- Reading labels and artwork for errors against approved text
- Coordination with plant, laboratory and marketing teams on deadlines
- Habit of confirming the current rule with the right authority rather than assuming
Education and experience
Preferred, never a bar: equivalent experience counts.
- B.Pharm, M.Pharm or B.Sc in life sciences preferred; a regulatory affairs course or diploma is useful
- Experience in regulatory work in a pharma or biotech firm is preferred
- Exposure to export market submissions is useful if your company supplies abroad
- What the role needs to know on regulation depends on the employer and products; confirm with your own adviser
How the work is judged
- Timeliness and completeness of submissions against the company's regulatory plan
- Quality of dossiers, judged by the number of queries and rework cycles raised
- Accuracy of the regulatory tracker and product files
- Handling of label and artwork reviews without errors reaching print
- Responsiveness to authorities, partners and internal teams on regulatory questions
Where the role can lead
- Senior regulatory affairs executive handling a market or product group
- Regulatory affairs manager leading submissions for domestic or export markets
- Move into quality assurance, pharmacovigilance or business development with relevant experience
Interview questions to ask
Ask every candidate the same questions in the same order and score them against written anchors, so the decision rests on the work and not the impression.
- Walk me through how you would assemble a dossier when the stability data from the plant is incomplete.
- An authority asks a query with a short deadline and the data owner is away. How do you manage it?
- You find the printed leaflet does not match the approved text. What do you do and who do you inform?
- How do you decide whether a manufacturing change needs to be notified before it is carried out?
- Describe a submission you worked on from start to approval. What was your part?
- How do you keep up with changes in regulatory guidance and make sure the team knows?
Hiring tips for this role
- Ask for a short exercise: summarise a sample product file and spot gaps. Writing quality and attention to detail matter more than jargon.
- Do not assume regulatory knowledge in general; ask which markets and product types the candidate has actually filed.
- Check that they have worked with plant and laboratory teams, because regulatory staff who stay at the desk often miss data issues.
- Remember that rules change. Hire for the habit of checking current requirements, not for memorised knowledge alone.
Questions about hiring a regulatory affairs executive
The executive prepares and files dossiers, tracks approvals and renewals, reviews labels and artwork, and answers queries from authorities and partners. The aim is to keep products approved and compliant with what was filed.
No. Quality assurance checks the plant and its records, while regulatory affairs deals with what is filed with authorities and approved for each product. The two work closely, since changes at the plant can affect filings.
Pharmacy or life science graduates are common. Any registration, licence or training depends on the employer, the state and the facts, so confirm what applies with your own adviser before advertising the role.
GullyHR agrees the job description with you, finds and screens candidates for the role and supports the offer. We hire for your permanent team and do not supply contract staff.
Hiring a regulatory affairs executive?
GullyHR runs talent acquisition for permanent roles. We agree the job description with you, find and screen candidates against it, and support the offer through to joining. We recruit permanent employees. We do not supply contract or temporary staff.