Syneos Health hiring Senior Regulatory Consultant in India for experienced professionals with CMC regulatory submissions and lifecycle management expertise roles
Introduction
Syneos Health is currently hiring experienced professionals for the role of Senior Regulatory Consultant. This opportunity is ideal for candidates with a strong background in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls) documentation and lifecycle management activities.
Professionals with expertise in global regulatory submissions and post-approval variations will find this role highly rewarding, offering exposure to international markets and complex regulatory projects.
Company Overview
Syneos Health is a globally recognized biopharmaceutical solutions organization that supports clinical development, regulatory processes, and commercialization services. The company collaborates with pharmaceutical and biotechnology clients worldwide, delivering integrated solutions across the product lifecycle. With a focus on innovation, compliance, and patient-centric outcomes, Syneos Health provides a dynamic work environment for regulatory and clinical professionals.
Job Overview
| Job Title | Senior Regulatory Consultant |
|---|---|
| Company Name | Syneos Health |
| Location | Bengaluru, Delhi NCR, Mumbai |
| Employment Type | Full-Time, Permanent |
| Qualification | Any Graduate |
| Experience | 6–11 Years |
| Salary | ₹11 – ₹18 LPA |
| Application Mode | Online Application |
Job Location & Employment Type
The role is open across multiple locations including Bengaluru, Delhi NCR, and Mumbai. It is a full-time, permanent position within the regulatory affairs domain, requiring collaboration with global teams and stakeholders.
Open Positions / Department Details
- Role: Senior Regulatory Consultant
- Department: Healthcare & Life Sciences (Regulatory Affairs)
- Industry: Pharmaceutical & Life Sciences
Key Roles & Responsibilities
- Prepare, author, and review Module 3 CMC documentation for regulatory submissions
- Manage post-approval variations and lifecycle maintenance activities in line with global regulations
- Support preparation and review of regulatory submissions such as EU variations (Type IA, IB, II), US submissions (CBE, PAS), and ROW filings
- Handle API and Drug Product (DP) related changes and documentation
- Manage site transfer activities and associated regulatory requirements
- Coordinate with cross-functional teams including Manufacturing, QA, QC, and Supply Chain
- Track project activities, timelines, and deliverables to ensure compliance with deadlines
- Participate in client meetings and provide regulatory expertise
- Identify potential issues and provide solutions for regulatory challenges
- Maintain effective communication with internal and external stakeholders
Eligibility Criteria
Education:
- Any Graduate (Life Sciences or Pharmacy preferred)
Experience:
- 6 to 11 years of experience in regulatory affairs
- Strong experience in CMC documentation and lifecycle management
- Experience with global regulatory submissions (EU, US, ROW) is essential
Skills Required:
Technical Skills:
- Expertise in Module 3 CMC authoring and review
- Knowledge of regulatory submissions and variation filings
- Experience in API and Drug Product lifecycle management
- Understanding of global regulatory guidelines (EU, US, ROW)
- Familiarity with site transfer and post-approval change processes
Soft Skills:
- Strong organizational and multitasking abilities
- Ability to work independently and manage deadlines
- Excellent communication and stakeholder management skills
- Problem-solving and analytical thinking
Salary & Benefits
- Salary Range: ₹11 LPA to ₹18 LPA
- Opportunity to work on global regulatory projects
- Exposure to international markets and guidelines
- Career growth in regulatory affairs and life sciences consulting
- Collaborative and inclusive work environment
Selection Process
The hiring process may include:
- Resume shortlisting
- Technical interview focusing on regulatory and CMC expertise
- Client or project-based discussion round
- HR interview and final selection
Candidates with strong experience in global submissions and regulatory strategy will have an advantage.
How to Apply
Interested candidates should apply through the official careers portal of Syneos Health. Ensure your resume clearly highlights your regulatory experience, CMC knowledge, and global submission exposure.
Why Apply for This Pharma Job?
This role offers an excellent opportunity for experienced regulatory professionals to work on complex global projects. At Syneos Health, employees gain exposure to diverse regulatory environments, including EU, US, and ROW markets. The position allows professionals to deepen their expertise in CMC documentation, lifecycle management, and regulatory strategy.
Additionally, working with a globally recognized CRO enhances career prospects and opens doors to leadership roles in regulatory affairs and pharmaceutical consulting.
Important Note / Disclaimer
PharmaJobHub.in is an independent job information platform. We do not provide any recruitment guarantee and are not affiliated with any company. Candidates are advised to verify details from official sources before applying.
Final Call-to-Action
If you have strong experience in regulatory affairs and are looking to advance your career, apply as soon as possible. Early applications may increase your chances of selection for this senior-level role.
