Kickstart Your Career in Regulatory Affairs: Join Precision For Medicine as a Regulatory Operations Associate
Are you detail-oriented, organized, and passionate about supporting global healthcare innovation? Precision For Medicine is looking for a Regulatory Operations Associate to join their growing team in India. This entry-level, full-time position is an excellent opportunity for early-career professionals to dive into the world of regulatory affairs and contribute to advancing clinical research.
About the Role
As a Regulatory Operations Associate, you’ll play a crucial role in the Regulatory Affairs department by ensuring the accuracy, compliance, and timely management of critical regulatory documents. This role is ideal for candidates with a keen eye for detail, strong organizational skills, and a drive to learn and grow in a global, fast-paced environment.
Key Responsibilities
Manage and organize regulatory documents using submission portals like CTIS and FDA eGateway.
Coordinate redaction of sensitive content to meet global compliance standards.
Assist with document preparation, formatting, and packaging for regulatory submissions.
Provide technical support, including converting documents into compliant formats.
Maintain tracking logs to monitor submission timelines and document status.
Stay updated on changing regulations and relay key updates to your team.
Actively participate in team meetings and project discussions.
Ensure all activities meet both regulatory guidelines and internal policies.
Who Should Apply?
We’re looking for candidates who are not only qualified but also motivated to grow in the dynamic field of regulatory operations.
Minimum Qualifications
A Bachelor’s degree or equivalent experience.
Proficiency in MS Office / Office 365.
Strong command of English (written and verbal).
1–2 years of experience in document management.
Preferred Qualifications
Background in clinical research, regulatory affairs, or related fields within CROs, pharma, or biotechcompanies.
Familiarity with CTIS and Clinical Trial Regulation (CTR) submissions.
Understanding of global regulatory bodies such as the FDA, EMA, etc.
Experience with tools like eTMF, Veeva Vault, or MasterControl, and submission formats such as eCTD.
Key Competencies
Impeccable attention to detail and document accuracy.
Strong time management and organizational skills.
Effective communication and team collaboration abilities.
Flexibility and readiness to adapt in a fast-evolving regulatory environment.
Why Join Precision For Medicine?
At Precision For Medicine, you’re not just starting a job — you’re building a career in a company that values innovation, quality, and global impact. Join a team that supports the development of groundbreaking therapies and works at the forefront of clinical research.
Ready to take the next step? Click here to apply and become part of a team that’s making a difference in healthcare every day.
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