Team Leader at United HR Solutions Pvt. Ltd.
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Executive - Regulatory Affairs - Pharma (1-5 yrs)
- B.Pharm / M.Pharm with 2-5 years experience in Regulatory Affairs with Medical Device / Medical Consumable / Pharmaceutical Companies
- Regulatory knowledge in handling pharmaceutical products as well as medical devices.
- Experience of preparation and submission of CTD in different countries for ROW market.
- Experience in handling queries received from NDRA in compliance to regulatory requirement.
- Experience in handling variations.
- Updated on various regulatory guidelines on WHO, EU and ICH.
- Should be energetic and passionate about work.
- Ability to maintain positive attitude when under pressure and in stressful situations.
- Good administrative skills.
- Experience in project management.
- Team player with good communication skills.
- Should be well structured and systematic.
- Regulatory experience in medical device industry (EU MDD/MDR, USFDA, Health Canada, IMDRF) or equivalent experience in a related field.
- Knowledge of Medical device quality management system (ISO 13485), Risk management (14971) would be added advantage.
- Responsible for coordination with supplier for arranging documents timely for dossier compilation.
- Concurrent follow-up with Country Manager, Agent and NDRA for ongoing submissions.
- Responsible for preparation, review and dispatch of registration dossiers for pharmaceutical products and medical devices as per application country guidelines.
- Preparation of technical files for CE marking based on branded and generic medical devices.
- Responsible for samples dispatch and to provide information to CM and agents.
- Review of registration dossiers (incl. SPC and leaflets).
- Ensure all activities related to Regulatory Affairs (RA) complies with Company's SOPs and regulatory / customer requirements.
- Responsible for evaluation, response preparation with supporting documents from supplier to query received from NDRA within deadlines.
- Coordination with cross-functional dept. on regulatory assistance
- Review of product layouts (labels, leaflets, SPCs) in line with regulatory guidelines pharmaceutical products and medical devices.
- Proactive and dedicated work on product registration ensuring meeting deadlines.
- To support activities within team and collaborate on the development of strategies, execution of projects and ad hoc tasks.