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