Regulatory / Sr Regulatory Associate (Module 1, Regulatory Submission) – Syneos Health, Pune, India
Job Summary
Syneos Health is seeking a Regulatory / Sr Regulatory Associate specializing in Module 1 and regulatory submissions at its Pune, India location. This role offers the chance to work on global biopharmaceutical projects, providing expertise in regulatory documentation and submission management while ensuring compliance with global health authority requirements.
Key Responsibilities
Prepare and review regulatory submission documents (Module 1) for global health authorities.
Coordinate with cross-functional teams to gather regulatory inputs.
Ensure the accuracy, consistency, and completeness of regulatory submissions.
Maintain knowledge of global regulatory requirements and guidance updates.
Assist in planning and execution of regulatory submission strategies.
Contribute to process improvement initiatives within the regulatory team.
Provide technical and document-level support during submission phases.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
Proven experience in regulatory submissions, specifically Module 1.
Strong understanding of global regulatory requirements and processes.
Excellent attention to detail and documentation skills.
Proficient in MS Office Suite (Word, Excel, PowerPoint).
Good communication and organizational skills.
Ability to work collaboratively in a matrix environment.
Perks & Benefits
Career development and progression opportunities.
Access to technical and therapeutic area training.
Peer recognition and comprehensive rewards program.
Inclusive and diverse Total Self work culture.
Opportunity to work on global regulatory projects.
Company Description
Syneos Health is a global leader in biopharmaceutical solutions, offering fully integrated clinical and commercial services across 110 countries. The company partners with top healthcare innovators to drive drug development and regulatory success worldwide.
Work Mode
On-site – Pune, Maharashtra, India
Call-to-Action
Ready to contribute your regulatory expertise to global biopharmaceutical innovations? Apply now to become a part of Syneos Health’s dynamic regulatory team.
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