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.
How to Apply
Application Link for Associate RA ( Module 1, regulatory submission) – IND-Remote
Application Link for Associate RA ( Module 1, regulatory submission) – IND-Gurugram-Hybrid
Application Link for Associate RA (Module 3, CMC) – IND-Remote
Application Link for Associate RA (Module 3, CMC) – IND-Gurugram-Hybrid
