Job Purpose

Support the Regulatory Affairs function in its pre-registration and/or post-registration dossier submission activities by assisting in data gathering, screening, collating and compiling of the eCTD dossiers, post-registration variations and any other documentation in order to submit the same to the Health Authorities for approval within the defined timelines as per overall objective of Austell.

Accountabilities

Perform pre-launch activities to ensure timeous submission and registration of products within the defined timelines.

Dossier Life Cycle Management- Perform the dossier life cycle management activities by supporting the post registration variations and other activities to ensure support to the regulatory function and its objectives.

Support and assist the administrative team in the responsibility to effectively manage and maintain dossiers (electronically and hard copies), collection and delivery of documents, ensure smooth operations and maintain quality standards.

Education Qualification

B Pharm /M Pharm

Relevant Work Experience

Relevant experience:

Minimum 3 years of experience in the regulatory function covering all areas, familiar with South African Market and other African territories could be an advantage.

eCTD experience in dossier compilation

Analytical skills, Attention to detail, Resilience, Collaborative approach will help perform this role effectively.

Competencies/Skills

Innovation Driven

Purpose Inspired

Integrity and Trust Anchored

Excellence Focused

Job Location

Mumbai

Job Purpose

Support the Regulatory Affairs function in its pre-registration and/or post-registration dossier submission activities by assisting in data gathering, screening, collating and compiling of the eCTD dossiers, post-registration variations and any other documentation in order to submit the same to the Health Authorities for approval within the defined timelines as per overall objective of Austell.

Accountabilities

Perform pre-launch activities to ensure timeous submission and registration of products within the defined timelines.

Dossier Life Cycle Management- Perform the dossier life cycle management activities by supporting the post registration variations and other activities to ensure support to the regulatory function and its objectives.

Support and assist the administrative team in the responsibility to effectively manage and maintain dossiers (electronically and hard copies), collection and delivery of documents, ensure smooth operations and maintain quality standards.

Education Qualification

B Pharm /M Pharm

Relevant Work Experience

Relevant experience:

Minimum 3 years of experience in the regulatory function covering all areas, familiar with South African Market and other African territories could be an advantage.

eCTD experience in dossier compilation

Analytical skills, Attention to detail, Resilience, Collaborative approach will help perform this role effectively.

Competencies/Skills

Innovation Driven

Purpose Inspired

Integrity and Trust Anchored

Excellence Focused

Job Location

Mumbai