Regulatory Affairs Specialist (Senior Role)

Ashland India Private Ltd
Full Time
₹18 Lakhs - ₹21 Lakhs
Mumbai, Hyderabad
Posted 1h ago

Regulatory Affairs Specialist (Senior Role)

Ashland India Private Ltd

Job description

Looking to lead regional product safety and regulatory strategy? Explore Ashland’s Regulatory Affairs Specialist role in Mumbai, overseeing customer regulatory support, market access, product stewardship, hazard communication, and compliance across South Asia.

Company Description 

Ashland is an additives and speciality ingredients company serving consumer and industrial markets, including pharmaceuticals, personal care, food and beverage, energy, construction, and coatings. Its Life Sciences business develops speciality ingredients and technologies for pharmaceutical applications, collaborating with customers on formulation and product-development challenges across international markets and industries worldwide.

Job Summary 

The role as a Regulatory Affairs Specialist provides regional leadership for Ashland’s Life Sciences portfolio across India, South Asia and assigned Rest of Asia markets, with support for Personal Care and Speciality Additives when required. The Regulatory Affairs Specialist coordinates customer regulatory responses, product compliance, registrations, product stewardship, hazard communication, regulatory intelligence, risk management, audits, and cross-functional process improvements to protect market access and regional business continuity.

Key Responsibilities 

  • Provides customer support on regulatory and quality issues in South Asia and the designated Rest of Asia areas.

  • Prepare and review product compliance statements, declarations, questionnaires, quality agreements and related technical documents.

  • Liaise with internal subject matter experts to provide accurate responses within stipulated time frames.

  • Support product registrations, notices, renewals, variations and regulatory maintenance tasks.

  • Conduct market entry evaluations, regulatory dossier preparation, analyze product labels and technical claims and assess regulatory implications of new product introductions, manufacturing adjustments and formulation changes.

  • Accountable for regional product stewardship operations such as hazard classification, SDS management, labeling, chemical inventory status, restricted substance declarations and hazardous products information.

  • Work with Toxicology, EHS, Quality, Manufacturing and Supply Chain departments to ensure product safety and regulatory compliance.

  • Monitor regulatory developments, legislation, guidelines, pharmacopoeia requirements and enforcement trends in assigned markets.

  • Develop regulatory alerts and response plans.

  • Maintain regulatory trackers Identify potential compliance and market-access problem.

  • Support internal and customer audits, inspection readiness, change control, deviations and corrective and preventive actions (CAPA).

  • Develop and maintain SOPs, work instructions, templates and training materials working with regional and global teams to improve regulatory procedures.

Educational Qualification 

  • A Bachelor's degree or above in Pharmacy, Pharmaceutical Sciences, Chemistry, Toxicology, Biology, Food Science, Chemical Engineering, or another relevant scientific discipline.

  • An advanced degree or relevant professional qualification is preferred for leadership readiness.

  • Typically 10 or more years of progressive experience in Regulatory Affairs, Product Stewardship, Quality, Technical Service, or Compliance.

Skills Required 

  • Skills within pharmaceuticals, pharmaceutical excipients, Active Pharmaceutical Ingredients (APIs), speciality chemicals, food and nutrition, personal care, or another regulated industry.

  • Demonstrated knowledge of Indian regulatory requirements and practical exposure to South Asian and selected Rest of Asia regulatory frameworks.

  • Strong experience in product stewardship, hazard communication, GHS classification, SDS and labelling requirements, chemical inventory management, and restricted substance management.

  • Experience managing customer regulatory enquiries, product compliance assessments, regulatory intelligence, registration activities, and change-control assessments.

  • Experience supporting regulatory registrations, authority interactions, audits, and regulatory impact assessments.

  • Familiarity with analytical testing, specifications, toxicology, and quality systems.

  • Experience using SAP, Salesforce, document-management systems, regulatory information-management tools, and SDS authoring systems.

Salary Structure 

The average salary of a Regulatory Affairs Specialist  at Syneos is ₹18-₹21 Lakhs per year.

 Career Development 

This role as a Regulatory Affairs Specialist, offers opportunities to develop regional expertise in product regulatory affairs, product stewardship, hazard communication, market access, and regulatory risk management. Experience leading cross-functional work across South Asia and Rest of Asia may support progression into regional regulatory leadership or broader product stewardship management roles.

How to Apply 

  • Open our job portal. Search for Regulatory Affairs Specialist  listing.

  • Review the full job information and check the eligibility conditions.

  • Fill out the application form.

  • Upload your resume.

  • Submit your application.

 

Employment Type: Full Time
Industry: Healthcare
Role Category: Non Clinical Jobs
Application: External (Company Site)

Education

Bachelor's Degree

Key Skills

Non Clinical JobsMedical AffairsPharmacovigilance
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Market insights & trends

Salary Insights

The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.

Hiring Trends

The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.

Frequently Asked Questions

Everything you need to know about the process

Jobslly curates specialized corporate healthcare listings tailored for medical graduates seeking a career pivot. Instead of sifting through general medical job boards, doctors can use our platform to directly access high-paying non-clinical opportunities in Pharmacovigilance, Medical Writing, and Clinical Trial Management with top pharmaceutical companies and CROs. Most MBBS/BDS grads don't realise — clinical background is already enough to get into pharma. The problem is nobody explains this clearly. On Jobslly each listing shows salary range, fresher eligibility, and certifications worth getting before applying. Pharmacovigilance roles for example keep asking for RQAP-GCP. All this is on the listing itself, no separate research needed.
Yes. Jobslly features dedicated filtering for remote and hybrid healthcare roles, which are highly sought after by medical professionals looking for better work-life balance. Doctors can easily track and apply for verified work from home positions, such as Telehealth Consultants, Medical Chart Reviewers, and Drug Safety Associates, directly through the platform Real problem with remote medical jobs — half are fake, half are badly described. You join and realise it's a night shift for a US team nobody mentioned. Jobslly listings show shift timings, contract type, whether company gives equipment or WFH allowance. All upfront before you apply.
Generic job portals often bury specialized clinical roles under thousands of unrelated listings. Jobslly is purpose-built exclusively for the healthcare and health-tech sectors. We provide doctors with targeted career alerts for niche specialties, direct application routes to premium employers in major hubs like Mumbai and Bangalore, and real-time insights into medical salary benchmarks. Salary benchmark is something doctors switching careers genuinely need. No idea what number to quote, quote low, stuck with it forever. Jobslly shows pay ranges — by role, city, experience level. Career alerts are filtered by specialty and location so inbox isn't flooded with irrelevant stuff daily.
To protect medical professionals from recruitment fraud and unverified agencies, Jobslly operates a strictly vetted ecosystem. We exclusively partner with verified employers, prioritizing NABH-accredited hospitals, established health-tech innovators, and recognized multinational pharma brands so you can apply with complete confidence. Fake agencies, ghost listings, upfront fee scams — very common in medical recruitment, especially pharma and international roles. Jobslly doesn't allow unregistered agents on platform at all. Each listing shows actual audit date, not just an old generic verified badge. Suspicious listing — report button is there, compliance checks within 24 hours.
Yes. Backed by the Academically Global network, Jobslly goes beyond domestic job listings by providing access to structured International Placement Programs. We connect ambitious doctors, nurses, and clinical staff with credible, high-paying healthcare contracts in global markets like the UK, Australia, and the UAE, while outlining the necessary credentialing steps. UK needs PLAB, Australia needs AMC, UAE needs DHA or HAAD depending on emirate. Most doctors know this but the full picture — exam pattern, timeline, cost, official links — is scattered everywhere. Jobslly puts the credentialing roadmap directly on each international listing. Academically Global counsellors also available — people who've actually placed Indian doctors in these countries, know exactly where candidates get stuck.
Forget the assumption that only senior doctors make the big money. That's outdated. Right now, some of the best packages in Indian healthcare are going to people you wouldn't expect — Senior Medical Writers, Clinical Data Managers, Pharmacovigilance Specialists working with global pharma firms or CROs. These aren't rare unicorn jobs. They exist, they hire regularly, and the salaries are negotiable in ways hospital jobs rarely are. Most candidates just don't know to look for them.
Not all cities are equal on this front, and applying blindly wastes time. Bangalore is where health-tech and clinical research hiring is concentrated. Hyderabad is pharma country – manufacturing, QC, formulation, R&D. Mumbai and Navi Mumbai handle specialized hospital care, advanced nursing roles, and pharmacovigilance admin, medical writing, policy work all coexist there without one dominating the other. If you're open to relocating, knowing this upfront changes which jobs you even bother applying for.
Both. That's the honest answer. Legitimate remote roles in healthcare have existed long before anyone started calling things "hybrid." Medical Coders, Pharmacovigilance Associates, Telehealth Coordinators, Freelance Medical Writers — these positions have been hiring remotely for years through companies that are very much real. The fake ones almost always have one thing in common: they ask for money. Registration fees, document processing charges, security deposits — whatever the label, it's a scam. No actual employer takes money from a candidate before they join. That rule holds without exception.
EMR platforms, digital documentation tools, data tracking systems, AI-assisted reporting software. These aren’t “nice to have” anymore. They’re baseline. Clinical Knowledge is still the foundation but walking into an interview unable to navigate the systems the team uses daily is a problem. Candidates who are already familiar with these tools don’t need to be trained from scratch, and that matters when hiring managers are comparing two otherwise similar profiles.
Short answer: yes, and it's happening constantly. Long answer: it depends on what you want. If structured hours, no emergency calls, and a salary that doesn't plateau after three years sound appealing — corporate healthcare is worth your attention. Medical Writing, Drug Safety Review, Insurance Auditing, Health-tech Program Management — these roles specifically want people who understand clinical realities. A nursing degree or MBBS isn't a handicap here. It's often the reason you get the interview.