Associate I, Regulatory CMC Strategy

Pfizer
Full Time
₹4 Lakhs - ₹9 Lakhs
Chennai, India
Posted 40m ago

Associate I, Regulatory CMC Strategy

Pfizer

Job description

Looking to build a career in regulatory CMC strategy? Explore this Associate I, Reg CMC Strategy role at Pfizer in Chennai.

 Company Description  

Pfizer is a healthcare company that is driven by a culture of individual ownership and shared purpose. The team strongly believes in its ability to shape the future of healthcare and to transform lives around the world. Pfizer keeps exploring therapies that can make a real difference for patients everywhere. The company welcomes talent who are eager to grow within its global regulatory community.

 Job Summary  

This role supports the Brands CMC Strategist within the License Renewals and Annual Reports team. As an Associate I, you will help prepare and submit CMC contributions for renewal and annual report applications in markets. You will work closely with the CMC Global Regulatory Strategist and cross‑functional teams to meet defined timelines. The role focuses on accuracy, compliance and strong regulatory documentation.

 Key Responsibilities 

  • Manage regulatory activities for assigned renewals and annual reports.

  • Support renewal strategists in preparing CMC contributions for markets.

  • Author or compile CMC sections for renewal applications following agreed timelines.

  • Coordinate with Pfizer Global Supply and other support teams as needed.

  • Apply regulatory guidelines when preparing renewal documentation.

  • Review supporting information before submission.

  • Update dossier. Flag risks or timeline delays early.

  • Coordinate internal documents. Required sign‑offs.

  • Review changes made during each reporting period for accuracy.

  • Author or compile CMC contributions for Annual Report submissions.

  • Confirm post‑approval changes and fulfilled commitments across systems.

  • Review stability contributions to ensure consistency with approved data.

  • Apply US guidelines to confirm correct filing classifications.

  • Develop justifications for changes submitted to health authorities.

  • Follow Pfizer's procedures and training requirements closely.

 Educational Qualification 

  • Postgraduate degree in Pharmacy or Science.

 Skills Required 

  • 0 - 1 year of experience in Regulatory Affairs within a pharmaceutical organization.

  • Excellent written and spoken English communication skills.

  • Strong conceptual, analytical and problem‑solving skills.

  • Good organizational skills. Close attention to detail.

  • Understanding of requirements for post‑approval changes.

  • Basic knowledge of retrieving information from databases.

  • Basic understanding of pharmaceutical manufacturing standards and processes.

 Salary Structure 

An Associate I in Regulatory CMC (Chemistry, Manufacturing, and Controls) Strategy typically earns an average annual salary ranging from ₹4.0 Lakhs to ₹9.0 Lakhs.

 Career Development  

This role offers hands‑on exposure to regulatory work within a leading pharmaceutical company. Pfizer also supports long‑term growth through mentorship, structured learning and opportunities to advance across affairs.

 How to Apply  

  • Visit our job portal and search for the Associate I, Reg CMC Strategy role - Pfizer.

  • Click on the job posting to read all the details about the job.

  • Fill in your details. Upload your updated resume.

  • Send your application.


Employment Type: Full Time
Industry: Healthcare
Role Category: Pharmacy
Application: External (Company Site)

Education

Postgraduate Degree (Master's/PhD)

Key Skills

PharmacyMedical Science LiaisonNon Clinical JobsClinical Research

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

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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.
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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.