Syneos Health Hiring Regulatory Consultant Jobs for EU CMC Module 3 with remote and hybrid opportunities in India.
Company Overview
Syneos Health is a globally recognized biopharmaceutical services organization that supports pharmaceutical and biotechnology companies across the full product lifecycle. The organization delivers integrated solutions spanning clinical development, regulatory affairs, medical writing, and commercial strategy. With a strong international presence and regulatory expertise across major health authorities, Syneos Health provides professionals the opportunity to work on complex global submissions while collaborating with multidisciplinary teams across regions. Hiring Regulatory Consultant Jobs
Job Location & Employment Type
- Work Locations:
- India – Remote (Pre-Approved)
- Gurugram, Haryana – Hybrid
- Employment Type: Full-Time
- Work Model: Remote / Hybrid (based on project and approval requirements)
Open Positions / Department Details
- Job Title: Regulatory Consultant – EU Market (CMC Module 3)
- Department: Regulatory Affairs – CMC
- Job Requisition ID: 25105260
This role is intended for experienced regulatory professionals with strong expertise in CMC Module 3 authoring, EU regulatory submissions, and post-approval lifecycle management activities. Hiring Regulatory Consultant Jobs
Key Roles & Responsibilities
The Regulatory Consultant will independently manage both non-complex and complex regulatory activities, supporting global regulatory strategies and execution. Core responsibilities include: Hiring Regulatory Consultant Jobs
- Reviewing existing product and development data against regional and global regulatory requirements
- Preparing and supporting gap analyses, regulatory development plans, and submission strategies
- Authoring and contributing to administrative and technical components of regulatory submissions, including INDs, MAAs, NDAs, and post-approval variation packages
- Supporting preparation of CMC Module 3 documentation for EU and other international markets
- Managing post-approval variations and lifecycle maintenance activities in compliance with regulatory guidelines
- Supporting regulatory agency interactions, including preparation of briefing packages and scientific advice materials
- Overseeing day-to-day regulatory activities for assigned projects in line with agreed timelines, scope, and budgets
- Providing regulatory expertise as part of cross-functional project teams throughout the product lifecycle
- Acting as a subject matter expert to resolve regulatory issues and support team members with technical guidance
- Preparing regulatory service estimates for proposals and supporting business development activities
- Participating in client meetings to discuss project progress, regulatory strategies, and deliverables
- Ensuring compliance with applicable global regulations and internal quality processes
- Developing training materials and sharing regulatory best practices internally and externally
- Supporting internal and external audits related to regulatory activities
- Contributing to the development and maintenance of SOPs and regulatory process documentation
- Providing oversight and guidance to junior regulatory team members
- Maintaining individual training records and completing all required organizational and client-specific training
Hiring Regulatory Consultant Jobs
Eligibility Criteria
Education
- M.Pharm is mandatory
- Bachelor’s or Doctoral degree in Pharmacy, Life Sciences, Chemistry, or a related scientific discipline may also be considered based on experience
Experience
- Minimum 4–5 years of hands-on experience in Regulatory Affairs
- Strong experience in CMC Module 3 authoring
- Proven exposure to post-approval variations and lifecycle management activities
- Hands-on regulatory experience with EU markets is essential
- Experience supporting GCC markets will be considered an added advantage
Skills Required
- In-depth knowledge of CMC regulatory requirements and global submission processes
- Strong experience supporting EU regulatory filings and maintenance activities
- Excellent written and verbal communication skills in English
- Advanced proficiency in Microsoft Office tools
- Strong analytical ability and attention to detail
- Ability to manage multiple regulatory projects simultaneously
- Capability to work independently while collaborating with cross-functional teams
- Strong problem-solving and decision-making skills
- High level of professionalism and customer-focused approach
Hiring Regulatory Consultant Jobs
Salary & Benefits
- Compensation: As per company norms
Employees typically benefit from structured career progression, technical and regulatory training, global project exposure, performance recognition programs, and a flexible work environment. Hiring Regulatory Consultant Jobs
Selection Process
The selection process may include:
- Resume and experience screening
- Technical interview focused on EU CMC Module 3 and lifecycle management
- Evaluation of regulatory strategy, communication, and analytical skills
- Final HR discussion and offer issuance
Only shortlisted candidates will be contacted.
How to Apply
Interested candidates should apply through the official company application channel.
- Application Mode: Online application via the employer’s career portal
Candidates are advised to clearly highlight EU regulatory experience, CMC Module 3 authoring, and post-approval activities in their resumes.
Important Dates
- Application Status: Open
Early applications are encouraged due to the seniority and specialization of the role. Hiring Regulatory Consultant Jobs
Why Apply for This Pharma Job?
This Regulatory Consultant position offers an excellent opportunity for experienced regulatory professionals to work on high-impact EU submissions within a globally reputed organization. The role provides autonomy, leadership exposure, and involvement in complex regulatory strategies across the product lifecycle. With remote and hybrid flexibility, global client interaction, and continuous professional development, this role is ideal for regulatory experts aiming to advance into senior consulting or leadership positions. Hiring Regulatory Consultant Jobs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform providing pharmaceutical and life sciences career updates for informational purposes only. We are not affiliated with Syneos Health or any hiring organization. Candidates should independently verify all job details and application procedures. IndiaPharmaJobs.in does not charge any fees for job listings or applications. Hiring Regulatory Consultant Jobs
Final Call-to-Action
If you have strong experience in EU regulatory affairs with CMC Module 3 expertise and are seeking a senior-level consulting role with global exposure, this opportunity offers an excellent platform for career advancement. Eligible professionals are encouraged to apply through the official application channel without delay. Hiring Regulatory Consultant Jobs
