Regulatory Writer

Amgen
Full Time
₹9 Lakhs - ₹12 Lakhs
Hyderabad
Posted 24m ago

Regulatory Writer

Amgen

Job description

Want to take your career in pharmaceutical regulatory affairs to the next level? Learn more about this opportunity at Amgen.

 Company Description   

Amgen is a global biotechnology company that uses biological research and technology to develop, manufacture, and deliver medicines for various diseases. With more than four decades of experience in biotechnology, the company focuses on scientific innovation and developing treatments that improve patients’ lives.

Job Summary  

The Regulatory Writer role is based in Hyderabad, Telangana, and is an on-site position within Amgen’s Regulatory department. The regulatory medical writer will independently prepare regulatory documents, manage review and approval processes, and ensure that documentation is scientifically accurate and consistent with source information. The position requires a master’s degree and relevant experience.

 Key Responsibilities   

  • Prepare regulatory documents independently, including Informed Consent Forms (ICFs), amendments, Plain Language Protocol Synopses (PLPSs), and Plain Language Summaries (PLSs).

  • Draft sections of Clinical Study Reports (CSRs), including synoptic, abbreviated, and standard reports, with appropriate guidance for pivotal reports.

  • Prepare protocol amendments, country-specific protocol supplements, and focused updates to Investigator’s Brochures (IBs).

  • Manage document versions, reviewer comments and approval processes from initial writing to finalization.

  • Ensure materials are scientifically defensible and internally consistent and congruent with source data and program objectives.

  • Prepare documents for quality control (QC) and regulatory inspection as required by all applicable guidelines, standard operating procedures and regulatory requirements.

  • Report any hazards, scope changes, or delays to your supervisor in a timely way.

  • Contribute to internal training and information exchange events and initiatives to improve documentation methods.

  • Strong scientific accuracy and consistency of written documentation.

  • Knowledge of regulatory guidance, standard operating procedures and document quality criteria.

  • Workflow control for document approval and versioning.

 
Educational Qualification   

  • A master’s degree is required.

  • Candidates must have related professional experience.

  • Relevant experience should align with regulatory writing and the preparation of clinical or regulatory documentation.

 
Skills Required   

  • Regulatory and clinical document writing.

  • Ability to prepare and edit informed consent forms, protocol amendments, clinical study report sections, and investigator brochure updates.

  • Conflict resolution and processing of reviewer comments in a constructive manner.

  • Project planning and managing multiple deliverables.

  • Able to detect risk, address documentation problems and fulfill deadlines.

  • Experience with document management systems, Regulatory Information Management (RIM) technologies, SharePoint and document authoring platforms.

  • Ownership, responsibility and attention to detail.

 
Salary Structure 

The average annual compensation of a Regulatory Writing Associate in India ranges between Rs.9 to Rs.12 Lakhs per annum.

 Career Development 

This role, as a scientific writer, provides opportunity to develop regulatory writing skills, handle complicated clinical documentation and to work with global clinical and regulatory teams. With expertise, professionals may transition into lead regulatory writer, regulatory writing manager or other senior clinical writer roles.

 How to Apply 

  • Search for the Regulatory Writer position on our job portal.

  • Click the link to get the full job description, qualifications and location of the work.

  • Fill in your information and upload your resume.

  • Submit your application.

 

 

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

Education

Postgraduate Degree (Master's/PhD)

Key Skills

Non Clinical JobsMedical Affairs

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.