Clarivate Hiring for Senior STEM Content Analyst CMC biologics expertise for regulatory submissions, content development, and global compliance operations.
Clarivate Recruitment 2025: Senior STEM Content Analyst – CMC Biologics (Hybrid, Chennai/Hyderabad)
Clarivate, a global leader in scientific intelligence, pharmaceutical insights, and regulatory data solutions, is hiring for the position of Senior STEM Content Analyst with specialized expertise in CMC Biologics. This hybrid role is available in both Chennai and Hyderabad, offering a dynamic career opportunity for experienced professionals in biologics development, regulatory affairs, and technical content management. Clarivate Hiring for Senior STEM Content Analyst CMC
This extensive job post provides a detailed overview of the role, responsibilities, required qualifications, preferred skills, and the complete application process. It is fully optimized for SEO, written in long-format style, and structured for publication on career websites, job portals, and company blogs.
About the Role: Senior STEM Content Analyst – CMC Biologics
As a Senior STEM Content Analyst, you will play a vital role in Clarivate’s Life Sciences team by authoring, managing, and curating high-quality CMC (Chemistry, Manufacturing, and Controls) content specifically related to biologics and biopharmaceutical products. Your work will support global regulatory submissions, contribute to content accuracy, and ensure compliance with evolving international guidelines. Clarivate Hiring for Senior STEM Content Analyst CMC
The ideal candidate will have hands-on experience with BLA (Biologics License Application), MAA (Marketing Authorization Application), and regulatory interactions with agencies such as FDA, EMA, and other global health authorities. This role requires strong domain expertise, attention to scientific detail, and the ability to interpret regulatory frameworks for biologics development and lifecycle management. Clarivate Hiring for Senior STEM Content Analyst CMC
Key Responsibilities (Expanded and SEO-Optimized)
The position involves a combination of scientific writing, regulatory analysis, content curation, and technical communication. Below is a detailed breakdown of the responsibilities associated with this role. Clarivate Hiring for Senior STEM Content Analyst CMC
1. Authoring High-Quality CMC Reports for Biologics
One of the primary responsibilities is to develop, review, and refine CMC documentation for regulatory submissions. This includes:
- Preparing CMC sections for BLA, MAA, and other global filings
- Ensuring the technical accuracy, clarity, and scientific consistency of documents
- Aligning content with global CMC regulatory strategies
- Assisting stakeholders in ensuring compliance with health authority requirements
High-quality documentation is essential for successful submissions, deficiency responses, and product lifecycle management.
2. Monitoring Global Regulatory Changes
Regulatory guidelines for biologics evolve constantly. You will be responsible for:
- Tracking updates from global regulatory agencies such as FDA, EMA, MHRA, PMDA, and others
- Evaluating the impact of new guidelines on CMC submissions
- Updating internal databases and content systems to reflect current requirements
- Ensuring that customers receive the most accurate and timely regulatory intelligence
This role requires analytical thinking, attention to detail, and a strong understanding of global regulatory landscapes. Clarivate Hiring for Senior STEM Content Analyst CMC
3. Curating and Updating CMC Database Content
Using internal expertise and external consultant networks, you will:
- Analyze changes in regulatory requirements
- Implement updates within Clarivate’s CMC database
- Ensure the repository aligns with global quality standards
- Contribute to both pre-approval and post-approval documentation frameworks
This ensures that customers and internal stakeholders always access updated and compliant CMC information.
4. Acting as Internal CMC Regulatory Expert
You will serve as a subject matter expert for CMC biologics for designated countries or regions. Your responsibilities include:
- Providing expert guidance to internal teams
- Supporting customer queries regarding regulatory pathways
- Representing CMC product insights during internal meetings
- Offering scientific and regulatory clarity for complex product scenarios
This expert role makes you a central point for regulatory knowledge sharing within the organization. Clarivate Hiring for Senior STEM Content Analyst CMC
5. Supporting CMC Product Manager and Customer Teams
You will collaborate with cross-functional teams and support key initiatives:
- Assisting CMC product managers with content strategy
- Providing regulatory insights to customer-facing teams
- Acting as a representative in client discussions when required
- Ensuring seamless communication between regulatory experts, content teams, and business units
This emphasizes teamwork, communication, and customer-oriented thinking. Clarivate Hiring for Senior STEM Content Analyst CMC
Required Qualifications
Below are the mandatory qualifications needed to be considered for this position:
Education
- Bachelor’s degree in Life Sciences
(Biotechnology, Biochemistry, Microbiology, Pharmaceutical Sciences, Biology, or related discipline)
This ensures strong scientific grounding relevant to biologics manufacturing and CMC processes. Clarivate Hiring for Senior STEM Content Analyst CMC
Experience
Candidates must have:
- Minimum 5 years of experience in pharmaceutical development, CMC manufacturing, or CMC regulatory affairs focused on biologics/biopharmaceuticals
- Experience handling BLA/MAA content and formatting requirements
- Practical exposure to FDA and EMA submissions
- Experience in:
- Responding to health authority deficiency letters
- Preparing regulatory communications related to biologics quality
- Expertise in navigating complex CMC regulatory issues
This role requires professionals with deep domain expertise and familiarity with biologics development pipelines. Clarivate Hiring for Senior STEM Content Analyst CMC
Preferred Qualifications (Added Advantages)
Candidates with the following skills will have an added advantage:
- Knowledge of biological entities such as monoclonal antibodies, vaccines, and recombinant proteins
- Experience in:
- Contract negotiations
- Managing budgets and invoices
- Understanding of copyright laws and local expert networks
- Experience working in structured regulatory intelligence or content teams
These additional competencies will enhance performance in content analysis and customer-oriented tasks. Clarivate Hiring for Senior STEM Content Analyst CMC
About the Team: Regulatory Market Access (CMC Unit)
This role is part of the Regulatory Market Access team, where CMC experts evaluate, curate, and maintain high-quality regulatory intelligence. The team: Clarivate Hiring for Senior STEM Content Analyst CMC
- Monitors global guidelines
- Ensures accuracy of regulatory content
- Supports both pre-approval and post-approval biologics documentation
- Works closely with regulatory consultants, subject matter experts, and global partners
It is a collaborative environment that values scientific accuracy, regulatory compliance, and continuous learning. Clarivate Hiring for Senior STEM Content Analyst CMC
Work Schedule and Mode
- Employment Type: Full-time, permanent
- Working Hours: 8-hour workday, flexible within 9:00 AM – 6:00 PM IST
- Workdays: Monday to Friday
- Work Mode: Hybrid (part office, part work-from-home)
This setup supports productivity, balance, and regular team collaboration.
Equal Opportunity Commitment
Clarivate ensures equal employment opportunities for all qualified individuals. Hiring decisions are made without discrimination on the basis of gender, ethnicity, disability, race, religion, or any other legally protected category. The company fully complies with relevant employment regulations in every region where it operates. Clarivate Hiring for Senior STEM Content Analyst CMC
How to Apply for Senior STEM Content Analyst – CMC Biologics
Follow the steps below to apply for this position:
- Prepare your updated resume emphasizing your biologics, CMC, and regulatory affairs experience.
- Visit the official Clarivate Careers Portal.
- In the search bar, enter the Job Requisition ID: JREQ133722.
- Select the role titled “Senior STEM Content Analyst” for Chennai or Hyderabad.
- Review the job details and click on Apply.
- Fill in the application form and upload your resume and required documents.
- Submit the application and monitor your email for further communication from Clarivate’s talent acquisition team.
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