Pharmaceutical Science Job at Syneos | Apply Now for the Associate RA Position
Are you passionate about global drug development and regulatory documentation? Syneos Health is hiring an Associate in Regulatory Affairs (Module 1, Regulatory Submission) to support its global regulatory operations. This Pharmaceutical Science Job at Syneos offers the opportunity to work with industry leaders, assist in preparing INDs, NDAs, and lifecycle maintenance activities, and be part of a team that’s accelerating the delivery of life-changing therapies worldwide.
- Job Post: Associate RA ( Module 1, regulatory submission)
- Location:Pune, Maharashtra, India
About the Company:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company translates unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. With over 29,000 employees across 110 countries, Syneos Health brings customers and patients to the center of every process. The company continuously looks for ways to simplify and streamline its work, making Syneos Health easier to work with and for.
Whether you join through a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers who innovate as a team to help customers achieve their goals.
Why Syneos Health:
- Passionate about developing people through career growth and progression.
- Supportive line management, technical and therapeutic training, and recognition programs.
- A “Total Self” culture that values authenticity and inclusion.
- A global team where diversity of thought and background fosters belonging and innovation.
Pharma Job Responsibilities:
- Assist with preparation of Module 1 documents and collection of country-specific administrative forms.
- Support regulatory submission documents including INDs, NDAs/MAAs, DMFs, renewals, variations, MATs, and other lifecycle activities.
- Prepare responses to Health Authority queries and track HA commitments.
- Maintain regulatory trackers, submission timelines, and ensure compliance with SOPs.
- Conduct regulatory research to identify precedents and support orphan drug designation requests.
- Archive submission documentation and ensure regulatory compliance.
- Assist clients and teams with general information, data gathering, and detailed report preparation.
Qualification Requirements for a Pharma Job:
- Master’s degree in Pharmaceutical Sciences or a related field.
- Minimum 2 years of experience in regulatory, quality, or document management support roles.
- Excellent communication and interpersonal skills.
- Strong proficiency in Microsoft Office Applications.
- Good time and project management skills preferred.
