Description

Senior Regulatory Associate (CMC - EU,APAC, gulf countries.)

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service setting, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone s life.
We are continuously building the company we all want to work for and our customers want to work with. Why Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

For non-complex submissions,



independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues:

- Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.

- Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.

- Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.

- Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements.

- Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client.

- Attends client meetings as needed and builds client relationship in support of projects and deliverables.

- Systematically reviews Regulatory Associates or other Senior Associate s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.

- Identifies risks to project delivery related to own workload and appropriate escalation. For identified non-complex issues, provide proposals for issue resolution.

- Assists in training and mentoring of team members depending upon project requirements.

- Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Regulatory Associate (CMC - EU,APAC, gulf countries.) (India)
🏢 Syneos Health
📍 India