Remote Jobs Regulatory Associate at Syneos Health for EU CMC Module 3 with remote and hybrid options for early-career professionals.
Company Overview
Syneos Health is a globally recognized biopharmaceutical solutions organization that supports pharmaceutical and biotechnology companies across clinical development, regulatory affairs, medical writing, and commercial operations. With operations spanning more than 100 countries, the organization partners with sponsors to accelerate the development and delivery of innovative therapies worldwide. Known for its integrated service model and strong regulatory expertise, Syneos Health provides professionals with exposure to global submissions, international regulatory standards, and large-scale lifecycle management activities. Remote Jobs Regulatory Associate
Job Location & Employment Type
- Work Locations:
- India – Remote (Pre-Approved)
- Gurugram, Haryana – Hybrid
- Employment Type: Full-Time
- Work Model: Remote / Hybrid (role-dependent)
Open Positions / Department Details
- Job Title: Regulatory Associate – EU Market (CMC Module 3)
- Department: Regulatory Affairs – CMC
- Job Requisition ID: 25105261
This position supports regulatory submissions and lifecycle activities with a primary focus on Chemistry, Manufacturing, and Controls (CMC) documentation for small molecule products, particularly for European Union markets. Remote Jobs Regulatory Associate
Key Roles & Responsibilities
The Regulatory Associate will work closely with internal regulatory teams and global clients to support regulatory documentation and submission activities. Key responsibilities include: Remote Jobs Regulatory Associate
- Supporting preparation of regulatory documentation related to product development and lifecycle management
- Assisting in the compilation and review of CMC Module 3 documents for small molecule products
- Contributing to regulatory submissions including INDs, NDAs, MAAs, DMFs, variations, renewals, and marketing authorization transfers
- Performing regulatory gap assessments and assisting with development planning documentation
- Supporting regulatory research activities to identify precedents, guidelines, and submission strategies
- Conducting quality checks to ensure regulatory documents meet current global and regional regulatory requirements
- Assisting with submission of regulatory dossiers in compliance with applicable regulations
- Supporting internal teams and external stakeholders with regulatory-related information
- Gathering, compiling, analyzing, and summarizing regulatory data for reporting purposes
- Managing routine correspondence and documentation related to regulatory projects
- Working on multiple projects simultaneously while adhering to project-specific instructions and timelines
This role requires strong attention to detail, documentation accuracy, and the ability to work within structured regulatory frameworks. Remote Jobs Regulatory Associate
Eligibility Criteria
Education
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, or a related discipline
- Equivalent qualifications or relevant academic exposure may also be considered
Experience
- Minimum 6 months to 2 years of experience in Regulatory Affairs
- Candidates with regulatory internships are strongly preferred
- Hands-on exposure to CMC documentation for small molecules is essential
- Prior experience supporting EU regulatory submissions is highly desirable
- Exposure to GCC or APAC markets will be considered an added advantage
Skills Required
- Strong understanding of CMC documentation and regulatory submission processes
- Familiarity with global regulatory guidelines and lifecycle management activities
- Excellent written and verbal communication skills in English
- Proficiency in Microsoft Office applications
- Strong organizational and time management skills
- High attention to detail and document accuracy
- Ability to work both independently and within cross-functional teams
- Capability to manage multiple assignments with varying requirements
- Analytical mindset with the ability to interpret regulatory information
Salary & Benefits
- Compensation: As per company norms
In addition to competitive compensation, the organization offers structured career development, technical training, exposure to global regulatory projects, peer recognition programs, and a supportive work culture. Remote Jobs Regulatory Associate
Selection Process
The selection process may include the following stages:
- Application screening based on education and regulatory experience
- Technical interview focusing on CMC and EU regulatory knowledge
- Assessment of documentation, communication, and analytical skills
- Final HR discussion and offer release
Only shortlisted candidates will be contacted for further steps. Remote Jobs Regulatory Associate
How to Apply
Interested candidates should apply through the official application process as specified by the employer.
- Application Mode: Online / Company career portal
Applicants are advised to ensure their resumes clearly highlight CMC exposure, regulatory submission experience, and relevant market knowledge.
Important Dates
- Application Status: Currently Open
Early applications are recommended due to high competition for remote and hybrid regulatory roles. Remote Jobs Regulatory Associate
Why Apply for This Pharma Job?
This Regulatory Associate position offers an excellent opportunity for early-career regulatory professionals to gain hands-on exposure to EU market submissions and CMC Module 3 documentation within a globally reputed organization. The role provides flexibility through remote or hybrid working options, exposure to multinational regulatory projects, and structured professional development. For candidates aiming to build a long-term career in global regulatory affairs, this position offers both learning depth and international visibility. Remote Jobs Regulatory Associate
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that publishes pharmaceutical and life sciences career opportunities for informational purposes only. We are not affiliated with Syneos Health or any hiring organization. Candidates should verify job details, eligibility, and application procedures directly with the employer. IndiaPharmaJobs.in does not charge any fee for job listings or applications. Remote Jobs Regulatory Associate
Final Call-to-Action
If you have early experience in Regulatory Affairs with exposure to CMC and EU submissions, this Regulatory Associate role offers a strong platform to grow within global pharma regulatory operations. Eligible candidates are encouraged to apply promptly through the official application channel. Remote Jobs Regulatory Associate
