- To prepare drug dossiers for API/Excipients and finished products for the local/regulated market. Must have working knowledge and be able to handle dossier compilation, submission and follow up independently.
- Manage Regulatory Affairs activities. To have good knowledge of global and Indian regulatory requirements. To prepare dossiers for registration of new as well as generic Products.
- To give inputs for the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs. To assure conformity of dossiers to the local statutory requirements.
- To assist in preparing dossiers for food ingredients/nutraceutical ingredients/ dietary supplements for the entire world. Be able and willing to read regulations and help with interpretations.
- Assist in establishing and tracking effective change control management coming for regulatory review and approval.
- Handle/response to the customer and regulatory queries.
- Filling and reviewing of customer questionnaire/checklist (VQ)
- Excellent attention to detail & accuracy in work
- Ability to work well independently as well as in a team environment, effective time management skills and ability to prioritize workload
- Training and guidance to subordinates
- Preparation of COA, MSDS.
- Preparation of STABILITY DATA, TDS, DMF, SDS
- Effectively follow the company’s standard operating procedures in submissions of documents.
- Experience of regulatory – Organic & Inorganic
Experience: 8+ years in regulatory affairs in a pharmaceutical industry
Educational Qualification : B.Sc. Chemistry
Job Location – Sandhurst Road (5 Minutes Walking distance from Sandhurst Road railway station.
Salary – Maximum 30 percent Hike over current salary
Job Type: Full-time
Pay: From $500.00 per month
Schedule:
Experience:
- ISO 9001: 1 year (Preferred)
Work Location: On the road