Recruiter HR at Kreative Organics
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Kreative Organics - Executive - Regulatory Affairs (4-8 yrs)
Designation: Executive (Regulatory Affairs USA, EU, JAPAN, ANVISA, TGA market)
- 3 to 6 years' work experience in international and domestic Pharma regulatory affairs.
- Confirmed knowledge of Global market regulatory requirements and ICH guidelines.
- Should have experience in eCTD DMF/Dossier preparation and review including life cycle management,specifically CMC writing & preparing module 1, 2 and 3 previously.
- Should have experience in handling of changes notification to customers and agencies
- Should have experience in renewal of facility registrations and drug listing activities.
- He/she has to work independently. There is no scope for supervision or team handling.
- Only M.Sc Chemistry preferably or complete experience in API industry for BPharm / MPharm .
Job Responsibilities :
- Preparing DMF/dossiers for regulated and semi-regulated markets.
- Preparation of documents for domestic license permissions.
- Gathering, evaluating, organizing and managing drug substances and intermediates regulatory information in a variety of formats.
- Handling of change notifications with the customers and regulatory agencies
- Maintaining Regulatory database up to date.
- Address customer complaints and queries within agreed timelines.
- Attending various customer and health authority audits held at the manufacturing site
- Keeping up-to-date with changes in regulatory legislation and guidelines
- Writing comprehensible, user-friendly, clear process description and impurity profile
- Ensuring that high quality standards are met and submissions meet strict deadlines.
Primary Skills :
- Understanding on API process and analytical methods development flow
- Knowledge on impurity profile, analytical method validations and stability studies.
- Knowledge on eCTD submission structure.
- Fluency in oral and written English.
- Able to build and maintain good communication with cross functional departments
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