Regulatory Affairs Associate Vacancies | Syneos Health


Syneos Health
Regulatory Affairs Associate Vacancies | Syneos Health, Pune
Apply for Senior Regulatory Associate (Module 1) at Syneos Health, Pune. MSc Pharma candidates with 4+ years of experience. Remote options available.
Syneos Health, a global leader in biopharmaceutical solutions, is inviting applications for the position of Senior Regulatory Associate (Module 1). This full-time opportunity based in Pune, India (remote flexibility) is ideal for professionals with a background in pharmaceutical sciences and regulatory documentation. If you’re passionate about compliance, drug submissions, and working in a dynamic clinical research environment, this role offers the perfect platform to grow your career.
Company Overview
Syneos Health is a world-renowned biopharmaceutical solutions company operating across 110 countries with a mission to accelerate clinical, medical, and commercial outcomes. With over 29,000 professionals worldwide, the company collaborates with top pharmaceutical and biotech organizations to deliver end-to-end drug development and commercialization services.
In the last five years alone, Syneos Health has contributed to:
- 94% of all Novel FDA Approved Drugs
- 95% of EMA Authorized Products
- Over 200 clinical studies across 73,000+ sites
Their culture of innovation, inclusivity, and integrity makes Syneos Health one of the most trusted names in global healthcare operations.
Job Role & Responsibilities
As a Senior Regulatory Associate (Module 1), you will play a critical role in ensuring global regulatory compliance and documentation excellence. The position involves preparation, coordination, and submission of critical regulatory dossiers in accordance with international standards.
Key Responsibilities:
- Prepare and compile Module 1 documents and gather country-specific administrative forms.
- Assist in the preparation of INDs, NDAs, MAAs, DMFs, and other regulatory submissions.
- Draft responses to Health Authority (HA) queries and ensure commitment tracking.
- Maintain regulatory trackers, submission timelines, and status reports for ongoing projects.
- Ensure accurate documentation archiving and compliance with internal SOPs.
- Conduct regulatory research to identify precedents, orphan drug designations, and policy updates.
- Support clients and internal teams by providing regulatory guidance and documentation insights.
- Manage correspondence and ensure smooth communication flow across regulatory affairs teams.
This role offers exposure to both regional and global submission strategies, giving you the chance to strengthen your expertise in international regulatory operations.
Eligibility / Qualifications
To qualify for this position, candidates must demonstrate strong regulatory experience combined with academic excellence.
Educational Qualification:
- Master’s degree in Pharmaceutical Sciences, Regulatory Affairs, or Pharmacology.
Preferred Courses:
Pharmaceutical Sciences, Drug Regulatory Affairs, Pharmacology, Quality Assurance, Pharmaceutical Chemistry.
Experience Required:
- Minimum 4 years of experience in regulatory affairs, quality documentation, or pharma compliance.
- Advanced proficiency in Microsoft Office applications.
- Strong analytical, project management, and communication skills.
Location & Salary
Work Location: Pune, Maharashtra (Remote work flexibility available)
Compensation: Competitive and commensurate with experience.
Syneos Health values its employees and provides comprehensive benefits including professional growth opportunities, cross-functional training, and global exposure.
Application Process
Interested candidates can apply directly via the official career portal using the link below:
👉 Apply Here – Syneos Health Career Portal
FAQs
Q1. Who can apply for the Senior Regulatory Associate position at Syneos Health?
Candidates with an M.Sc. in Pharmaceutical Sciences and 4+ years of regulatory experience are eligible.
Q2. Is remote work available for this position?
Yes, the role offers remote flexibility within India.
Q3. What are the main responsibilities of this role?
Key responsibilities include regulatory documentation, Module 1 submissions, Health Authority communication, and tracking compliance reports.
Q4. How can I apply?
Apply via the official Syneos Health portal.
Q5. What is the expected salary range?
The salary is competitive and depends on experience, current CTC, and role fitment.
Call to Action
Don’t miss this opportunity to join a global leader in pharmaceutical development.
Apply now to be part of a mission-driven team transforming healthcare innovation!
Limited openings – Apply before slots fill up!
Summary Table
Category | Details |
---|---|
Company | Syneos Health |
Vacancies | Senior Regulatory Associate (Module 1) |
Required Education | M.Sc. in Pharmaceutical Sciences, Regulatory Affairs, Pharmacology |
Experience | Minimum 4 years in regulatory or quality documentation |
Location | Pune, Maharashtra (Remote available) |
Salary | Competitive, based on experience |
Application Link | Apply Here |
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.