Regulatory Consultant Job at Syneos Health
Location: Remote / Gurugram (Hybrid)
Job Type: Full-Time
Job Requisition ID: 25101141
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company brings together clinical development, medical affairs, and commercial expertise to deliver integrated solutions that help life sciences organizations develop and commercialize new therapies efficiently. Regulatory Consultant Job at Syneos Health
With more than 29,000 employees across 110 countries, Syneos Health partners with major pharmaceutical and biotechnology companies to transform innovative ideas into life-changing healthcare solutions. The organization emphasizes agility, collaboration, and innovation in everything it does. Regulatory Consultant Job at Syneos Health
Job Overview
Syneos Health is hiring a Regulatory Consultant (CMC/ EU Market Experience) who will be responsible for preparing, managing, and overseeing regulatory submissions and lifecycle management activities for pharmaceutical products, with a strong focus on the European Union (EU) market. Regulatory Consultant Job at Syneos Health
The role involves hands-on experience in authoring and reviewing Module 3 (CMC) sections, developing submission strategies, and ensuring compliance with regulatory requirements. The consultant will work closely with cross-functional teams, clients, and global regulatory authorities to deliver high-quality regulatory support and documentation. Regulatory Consultant Job at Syneos Health
Key Responsibilities
- Prepare and review Module 3 (CMC) sections for post-approval CMC variations, renewals, annual reports, and other lifecycle management activities in compliance with current regulatory guidelines.
- Assess change controls issued by quality or regulatory departments, evaluate their regulatory impact, and develop submission strategies accordingly.
- Conduct detailed research of product data to prepare gap analyses, development plans, and other regulatory submissions aligned with global and regional requirements.
- Contribute to or prepare technical and administrative sections of regulatory agency submissions including IND, NDA, MAA, PMA, and CTD (electronic submissions).
- Prepare briefing packages for regulatory meetings or scientific advice and support agency interactions.
- Manage and operationalize the delivery of day-to-day regulatory activities for assigned projects according to timelines, scope, and budget.
- Participate as regulatory support on cross-functional teams involving R&D, clinical, quality, and manufacturing professionals to ensure regulatory compliance throughout the product lifecycle.
- Act as a subject matter expert (SME) for regulatory CMC processes and assist team members in troubleshooting issues and ensuring compliance with applicable standards.
- Support client meetings and business development discussions by providing regulatory insights and project status updates.
- Ensure compliance with relevant global regulations and company policies, maintaining thorough and up-to-date documentation.
- Participate in internal and external audits, regulatory reviews, and contribute to the creation or maintenance of SOPs and process-related documents.
- Provide oversight and guidance to junior team members and maintain required training documentation and certifications.
- Regulatory Consultant Job at Syneos Health
Qualification Requirements
Education:
- Master’s degree (MS or M.Pharm) or PhD in Life Sciences, Pharmacy, Chemistry, or a related discipline.
Experience:
- Minimum of 5 years total experience, including at least 4 years in Regulatory Affairs (CMC).
- Hands-on experience with EU market regulations is mandatory. Experience in GCC (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, UAE) and MEA markets will be an added advantage.
- Proven experience with post-approval CMC variations, renewals, and regulatory submissions.
- Strong understanding of global regulatory frameworks and lifecycle maintenance processes.
Technical Skills:
- Proficiency in authoring regulatory documents in CTD format.
- Familiarity with regulatory systems such as Veeva RIMS and TrackWise preferred.
- Strong working knowledge of Microsoft Office applications.
Soft Skills:
- Excellent written and verbal communication skills in English.
- Strong analytical, organizational, and time management skills.
- Ability to manage multiple projects simultaneously and meet deadlines under pressure.
- High attention to detail and accuracy.
- Strong initiative, adaptability, and proactive approach to problem-solving.
- Ability to work both independently and as part of a cross-functional team.
Why Join Syneos Health
Syneos Health offers an inclusive and supportive work environment that prioritizes employee growth, development, and well-being. Regulatory Consultant Job at Syneos Health
- Continuous career development and training opportunities.
- Engaged leadership and supportive management.
- Recognition and rewards for outstanding performance.
- Exposure to global markets and diverse therapeutic areas.
- A strong focus on diversity, equity, and inclusion under the “Total Self” culture, encouraging employees to bring their authentic selves to work.
About Syneos Health’s Impact
In the past five years, Syneos Health has partnered on:
- 94% of all FDA-approved novel drugs.
- 95% of EMA-authorized products.
- Over 200 studies conducted across 73,000 sites and 675,000+ clinical trial patients.
This track record reflects the company’s dedication to advancing healthcare and improving patient outcomes worldwide. Regulatory Consultant Job at Syneos Health
For more details, visit the official website: www.syneoshealth.com
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