Regulatory Start Up Associate Ii

15 hours ago

Bengaluru, India Novotech Asia Full time

**Brief Position Description**:
**Minimum Qualifications & Experience**:

- Graduate in a clinical, pharmacy or life sciences related field.
- At least 1-2 years Regulatory Start-up experiences in a CRO.

**Responsibilities**:

- Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
- Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals.
- May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards, and other local authority related activities.

Ensure submission packages are accurate and complete per local requirements.

Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

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