Regulatory Affairs Job Clinical Trial Submissions at Novotech
Novotech, a leading global Contract Research Organization (CRO), is currently hiring for the position of Senior Regulatory Start-Up Associate in Bangalore, India. This is a crucial regulatory affairs role, focused on managing clinical trial submissions and ensuring compliance with international and local regulatory standards. Regulatory Affairs Job Clinical Trial Submissions
If you are a regulatory affairs professional with 3–5 years of experience, and have a background in pharmacy, life sciences, or clinical research, this opportunity offers a chance to work with one of the most reputable CROs in the world.
About Novotech
Founded in 1997, Novotech has grown into one of the most respected full-service CROs with operations across Asia-Pacific, North America, and Europe. Known for its scientific expertise, operational excellence, and robust regulatory support, Novotech provides high-quality clinical development services to the biotech sector. Regulatory Affairs Job Clinical Trial Submissions
The company’s continued growth is fueled by its commitment to innovation, regulatory compliance, and a supportive workplace culture that fosters professional development.
Job Overview
Position: Senior Regulatory Start-Up Associate
Department: Regulatory Affairs / Clinical Trial Submissions
Location: Bangalore, Karnataka
Experience Required: 3 to 5 years
Work Type: Full-time (Flexible work options available)
Industry: Clinical Research Organization (CRO)
Last Date to Apply: June 20, 2025
Key Responsibilities
The selected candidate will play an important role in clinical trial start-up operations, primarily focusing on ethical and regulatory submissions for multiple sites and regions. Responsibilities include: Regulatory Affairs Job Clinical Trial Submissions
- Serving as the primary contact for Regulatory Start-Up Managers (RSMs) and Project Managers (PMs) during clinical trial start-up phases.
- Preparing, reviewing, and submitting required documentation to Ethics Committees (ECs), Institutional Review Boards (IRBs), and Regulatory Authorities.
- Ensuring all documentation complies with ICH-GCP guidelines, country-specific regulations, and internal SOPs.
- Maintaining and updating regulatory tracking systems with submission and approval timelines.
- Managing Informed Consent Form (ICF) customizations according to local regulatory requirements.
- Coordinating clinical trial registrations, amendments, and safety report submissions.
- Collaborating with internal teams and external stakeholders including sites and authorities.
- Supporting the training of junior regulatory staff and contributing to continuous process improvement.
Eligibility Criteria
Educational Qualification
Applicants must possess a degree in one of the following disciplines: Regulatory Affairs Job Clinical Trial Submissions
- Bachelor’s or Master’s in Pharmacy (B.Pharm / M.Pharm)
- Pharm.D
- B.Sc / M.Sc in Life Sciences, Biotechnology, Clinical Research, or related fields
Work Experience
- Minimum of 3 years and up to 5 years of hands-on experience in regulatory start-up or clinical trial submission roles, preferably in a CRO, pharmaceutical company, or clinical research organization.
Required Skills
- In-depth knowledge of local and global clinical trial regulations
- Experience preparing and submitting Regulatory Authority and EC/IRB documents
- Familiarity with clinical trial registration platforms and safety reporting procedures
- Excellent verbal and written communication skills
- Strong project management and organizational skills
- Ability to multitask and manage deadlines across multiple projects
- Proficiency with tracking systems and regulatory documentation tools
Why Join Novotech?
Novotech offers a highly supportive and forward-thinking work environment designed for regulatory professionals seeking career progression in clinical research. Here’s what you can expect: Regulatory Affairs Job Clinical Trial Submissions
- Flexible working arrangements with remote work options
- Paid parental leave and employee wellness programs
- An inclusive culture that supports employees from LGBTIQ+, disability, and caregiver communities
- Continuous training and opportunities for advancement in the biotech and pharma sectors
- Industry certifications including ISO 27001 and ISO 9001, reflecting strong quality and data security standards
How to Apply
If you’re interested in being part of a globally recognized CRO that values regulatory compliance, innovation, and employee development, you are encouraged to apply before the application deadline.
Application Deadline: June 20, 2025
To apply, visit the official Novotech careers page or apply through verified job portals. Ensure your resume highlights your regulatory affairs expertise, document management experience, and familiarity with clinical research processes. Regulatory Affairs Job Clinical Trial Submissions
Final Note
The Senior Regulatory Start-Up Associate role at Novotech offers a unique opportunity to work at the intersection of regulatory compliance and clinical trial operations. With exposure to global studies, evolving regulations, and a world-class team, this position is perfect for professionals looking to elevate their careers in regulatory affairs and clinical research. Regulatory Affairs Job Clinical Trial Submissions
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