GSK – Regulatory affairs Executive Vacancies – Mumbai

• MAINTAINING GOVERNANCE & COMPLIANCE
• LABELLING REVIEW AND APPROVAL
• MANAGEMENT OF API LICENCES FOR LOCAL PRODUCTS:
• COMPLETING MANDATORY & ROLE SPECIFIC TRAININGS

GSK Recruitment Notification for Executive – Regulatory Affairs Position at Mumbai Location. Interested & Eligible Candidates apply Now

Work location : Worli Mumbai, India
Department : Regulatory

Responsibilities:

MAINTAINING GOVERNANCE & COMPLIANCE

• Assist Regulatory compliance manager in Planning and conduct of Management Monitoring as scheduled to assess effectiveness of controls.
• Track and ensure timely closure of all remedial, Corrective and Preventive actions as and when arising.
• Liaise with RA team member and LOC quality team for any open change control and ensure closure as per timelines.
• Support implementation of Internal Control Framework (ICF) for regulatory affairs function.
• Administrator for maintaining all local Regulatory Affairs SOPs
• Assist in Identifying, assessing, and communicating, all relevant Regulatory Intelligence received from external or internal sources.
• Assist Regulatory compliance manager, in preparing dashboard for Regulatory function.

LABELLING REVIEW AND APPROVAL

• Author and update Product Prescribing Information.
• Perform QC checks to ensure prescribing Information tracker is up to date.
• Administrator for Prescribing Information for ensuring accurate archival of electronic records.

MANAGEMENT OF API LICENCES FOR LOCAL PRODUCTS:

• Compile dossiers for import license for locally manufactured product and ensure timely submission and approval of the same to achieve supply as per GSK Requirement.

COMPLETING MANDATORY & ROLE SPECIFIC TRAININGS

Ensure Completion of  mandatory Regulatory trainings for self and Team member in a timely manner.

• At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally.
• We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

Minimum qualification : B Pharmacy

Preferred- Post graduate in Pharmacy Or Science

Note:

• GlaxoSmithKline does not charge any fee whatsoever for recruitment process.
• Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
• GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
• All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK