Job Description:
- Create and review regulatory documentation for drug, device, and combination product renewals, and life cycle maintenance-related submissions.
- Interact with non-regulatory support groups (manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals and submissions.
- Track status and progress of regulatory documentation.
- Coordinate and compile responses to regulatory authority questions (under supervision).
- Use an electronic document management system to compile documents for submissions to health authorities.
- Answer internal queries for assigned products.
- Maintain a database of regulatory requirements for renewals.
- Support other regulatory processes including device establishment registration, drug listing, structured product labeling, and processing requests for certificates and legalization.
Candidate Profile:
- 6+ years of regulatory experience within a healthcare environment.
- Bachelor’s degree or equivalent in a relevant scientific discipline (Non-scientific degrees may be accepted with further training or an apprenticeship).
- Knowledge of regulations in healthcare.
- Scientific knowledge and strong administrative and project management skills.
- Ability to multitask, prioritize, and contribute to multiple projects from a regulatory perspective.
- Strong interpersonal and communication skills.
- Proficient with technical systems (word processing, spreadsheets, databases, online research).
- Proofreading and editing skills.
- Ability to independently identify compliance risks and resolve or escalate as necessary.
Additional Information:
- Experience: 6+ years
- Location: Bengaluru, Karnataka
- Industry Type: Pharma/Healthcare/Clinical Research
- Functional Area: Regulatory Affairs
- End Date for Application: 10th December 2024
For candidates with the required experience and qualifications, this is a great opportunity in a leading global healthcare company.