Syneos Health Hiring Regulatory Associates in India (Entry to Associate)

Published on

August 10, 2025

Regulatory Associates

Syneos Health

MSc /M.Pharm

Remote & hybrid

6 Months - 3 Years

Verified Job

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Syneos Health, a global leader in biopharmaceutical solutions, is hiring Regulatory Associates for Module 1 (Regulatory Submission) and Module 3 (CMC) roles in India. With opportunities in remote and hybrid (Gurugram) settings, these positions offer a chance to work with a company that has contributed to 94% of FDA-approved novel drugs and 95% of EMA-authorized products over the past five years. If you’re passionate about advancing clinical development and regulatory affairs in a dynamic, patient-centric environment, Syneos Health is the place for you. Discover how you can contribute to life-changing therapies with a team of 29,000 professionals across 110 countries.

Job Responsibilities

Associate RA (Module 3, CMC)

Independently prepare Module 3 sections for post-approval CMC variations, renewals, annual reports, and lifecycle maintenance activities, ensuring compliance with government regulations.
Prepare and submit components of INDs, marketing applications, and lifecycle maintenance submissions under supervision for complex projects.
Utilize Veeva RIMS for creating objectives and submission content plans (preferred experience).
Conduct Quality Control reviews of documents and manage submissions until final delivery.
Attend client meetings, build relationships, and identify/escalate project risks.
Assist in training and mentoring team members as needed.
Maintain regulatory databases and individual training records per Syneos Health standards.

Associate RA (Module 1, Regulatory Submission)

Assist in preparing Module 1 documents and country-specific administrative forms.
Support regulatory submissions, including INDs, NDAs/MAAs, DMFs, variations, renewals, and marketing authorization transfers.
Respond to Health Authority queries and track commitments.
Maintain and update regulatory trackers, submission timelines, and status reports.
Ensure proper archiving of submission documents per internal SOPs.
Conduct regulatory research to support orphan drug designation requests.
Gather information and prepare detailed reports or correspondence.

Qualifications

Associate RA (Module 3, CMC)

MS/M.Pharm or equivalent combination of education and experience.
Minimum 6 months (Regulatory Associate) or 1.5 years (Senior Regulatory Associate) experience in regulatory affairs.
Hands-on experience with RIM systems (e.g., Veeva RIMS, Trackwise) preferred.
Advanced skills in Microsoft Office applications.
Strong analytical and interpersonal/communication skills.
Ability to work independently, follow detailed instructions, and manage concurrent projects.
Fluency in English (speaking, writing, reading).

Associate RA (Module 1, Regulatory Submission)

Masters in Pharmaceutical Sciences.
Minimum 2 years of experience in a regulatory, quality, or document management support role.
Advanced proficiency in Microsoft Office.
Strong time and project management skills.
Excellent interpersonal and communication skills.
Fluency in English.

Benefits of Working at Syneos Health

Career Development: Access to technical and therapeutic area training, peer recognition, and a total rewards program.
Total Self Culture: A supportive environment where you can authentically be yourself, fostering diversity and inclusion.
Global Impact: Work on projects that accelerate the delivery of life-changing therapies, collaborating with a global team.
Flexible Work Options: Choose between remote or hybrid (Gurugram) work arrangements.
Supportive Management: Engaged line management and opportunities for career progression.