Job Title: Regulatory Consultant
Updated: April 28, 2025
Location: India (Home-Based, Asia-Pacific)
Job ID: 25003301
Company: Syneos Health
Position Summary
Syneos Health is hiring a Regulatory Consultant to support global regulatory submissions and life-cycle management activities. The role involves preparing and reviewing components of submissions such as INDs, NDAs, MAAs, and CTDs, engaging in client communications, ensuring compliance with global regulatory requirements, and contributing to post-approval activities for the EU and Global ROW markets. This role is suited for science graduates or professionals with relevant regulatory experience in the pharmaceutical or medical device industry.
Key Responsibilities
Conduct research and prepare regulatory strategy documents, development plans, and gap analyses.
Write and contribute to regulatory submissions (e.g., INDs, NDAs, MAAs, CTDs, briefing documents).
Lead or support regulatory activities throughout the product lifecycle, including post-approval changes.
Provide regulatory support in multidisciplinary teams and client meetings.
Manage day-to-day delivery of assigned regulatory projects within timelines and budget.
Prepare or review training materials, SOPs, and internal documentation.
Support change control assessments and regulatory strategy preparation.
Maintain up-to-date training records and participate in audits and cross-functional initiatives.
Required Qualifications
Education: BS, MS, or PhD in life sciences or related field.
Experience:
Moderate experience in pharmaceutical or medical device regulatory affairs.
Hands-on experience with global submissions (e.g., IND, NDA, PMA, MAA) and electronic CTD submissions.
Experience with post-approval submissions for Global ROW and EU preferred.
Skills:
Strong communication, project management, and analytical skills.
Proficient in Microsoft Office.
Ability to manage multiple projects and adapt to varying requirements.
Familiarity with global regulatory agency requirements and change control processes.
Fluent in English (spoken and written).
Why Join Syneos Health
Collaborate with global teams that have contributed to over 94% of novel FDA drug approvals in the last five years.
Grow your regulatory expertise through challenging global projects and continuous learning opportunities.
Be part of an inclusive culture that values authenticity and professional development.
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