Novotech Hiring for Regulatory Affairs / Senior Regulatory Start-Up Associate
Location: Bangalore, Karnataka
Application Mode: Online
Last Date to Apply: June 20, 2025
Are you an experienced regulatory professional looking to contribute to global clinical research? Novotech, a leading global Contract Research Organization (CRO), is hiring for the position of Senior Regulatory Start-Up Associate in Bangalore. This role focuses on regulatory submissions and ethics approvals for clinical trials and is ideal for professionals with 3–5 years of experience in the regulatory or clinical trial domain. Novotech Hiring for Regulatory Affairs
About the Company – Novotech
Novotech is a globally recognized CRO with a strong presence across Asia-Pacific, North America, and Europe. The company specializes in clinical trial services for the biotechnology sector and is committed to high-quality research standards, holding both ISO 27001 and ISO 9001 certifications. Novotech Hiring for Regulatory Affairs
Job Role: Senior Regulatory Start-Up Associate
Location:
Bangalore, Karnataka
Department:
Regulatory Affairs – Clinical Trials
Experience Required:
3 to 5 years
Qualification:
- B.Pharm / M.Pharm
- Pharm.D / M.Sc / B.Sc in Life Sciences
- Clinical Research or related fields
Key Responsibilities
- Act as the primary liaison between Regulatory Start-Up Managers (RSM) and Project Managers (PM) during clinical trial initiation.
- Prepare, review, and submit regulatory documents at both country and site levels including EC/IRB and Regulatory Authority applications.
- Ensure all submissions comply with ICH-GCP, local, and international regulatory requirements.
- Track and update systems with submission timelines, deadlines, and approvals.
- Interact with Ethics Committees, Regulatory Authorities, and clinical sites.
- Customize Informed Consent Forms (ICFs) to meet local regulatory standards.
- Support trial registrations, safety report submissions, and amendment filings.
- Assist in process improvement initiatives and mentoring junior staff.
Required Skills & Experience
- 3–5 years of experience in regulatory start-up or clinical trial submissions.
- Strong understanding of ICH-GCP guidelines and regional regulatory frameworks.
- Excellent skills in documentation, submission tracking, and stakeholder communication.
- Prior experience in a CRO or pharmaceutical company preferred.
- Ability to work independently in a fast-paced and regulated environment.
- Novotech Hiring for Regulatory Affairs
Why Join Novotech?
- Opportunity to work with a globally respected CRO with international clients.
- Flexible work arrangements and paid parental leave.
- Inclusive culture supporting LGBTIQ+, disability, and caregiver diversity.
- Strong career development pathways in regulatory affairs and clinical operations.
- Work on high-impact global clinical trials with cutting-edge biotech companies.
How to Apply
Interested and eligible candidates can apply online through the official Novotech careers page or other job platforms. Novotech Hiring for Regulatory Affairs
Last Date to Apply: June 20, 2025
Application Mode: Online only
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