Ascent Meditech - Senior Executive/Assistant Manager - Regulatory Affairs

Department / Function: Corporate Division : AML

Job Title : Regulatory Affairs Sr Executive / Assistant Manager Reporting to : Chief Executive Officer

JOB SUMMARY:

- Coordinating with manufacturing unit for the documents required for registration process and replying queries reply.

- Preparing dossier for registration & Re-registration for exporting countries as per respective countries guideline and handling queries related to registration.

- Coordinating with artwork department for the development of artwork as per countries requirement.

- Checking outer carton Sticker label for export order for some countries i.e. Algeria, Jordan , Iraq etc.

- Arranging and sending samples required for registration purpose.

- Legalization from Embassy, Attestation from Chambers of documents for registration purpose as per countries requirement.

- Sending packing instruction to factory for export order and handling queries related to it, if any. For new party or country getting confirmation from party for packing instruction.

- Arranging for the documents required for local tender purpose.

- Identifying products for both local & export tender.

- Registration with Government institute like CPC & CSD - Coordinating with plant and consultant to arrange for the documents required for registration .

- Arrange for the documents for registration and handling queries for applying License with CDSCO.

- Free Sale Certificate - arranging documents for applying FSC.

Monthly - Updating Registration status of the products registered.

Yearly :

- Maintaining renewal of Quality certificate (i.e. ISO 9001, ISO 13485 , CE Certificate, USFDA Certificate, Export house, License, Pollution Control Certificate, Non -Conviction Certificate, Manufacturing & Marketing Certificate etc.)

- Quality Certificate Audit - Coordinating with plant and auditing agency to arrange for required documents for audit purpose and scheduling the audit and also ensuring that all the NC are closed on given timeline.

QUALIFICATIONS / EXPERIENCE REQUIRED:

- Excellent verbal and written communication skills.

- Excellent interpersonal and customer service skills.

- Excellent organizational skills and attention to detail.

- Excellent time management skills with a proven ability to meet deadlines.

- Strong analytical and problem-solving skills.

- Strong supervisory and leadership skills.

- Proficient with Microsoft Office Suite or related software.