Job Description

Job Description:

• 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