Regulatory Affairs Pharmacist - Antibiotic at GlaxoSmithKline (GSK)

Job description

Qualification

Basic qualifications:

B.Pharm.

Work Experience

• 3 – 5 years practical experience in regulatory and manufacturing environment
• Computer Literacy.
• Exposure to medicine registration course presented by competent institution preferable.

Details

Preferred qualifications:

Job Purpose

To manage the life-cycle of Antibiotic and registered Dermatology product brand registrations in accordance with MCC requirements and GSK standards as directed by the Head of Regulatory Affairs.

To manage the Antibiotic and registered Dermatology product brand portfolio and provide regulatory support and product information to all related functions.

Scope

No subordinates.

Contributes to the life-cycle management of the entire GlaxoSmithKline Antibiotic and registered Dermatology product brand ranges.

Essential Job Responsibilities

Regulatory

Manages product brand life-cycle and updates all Antibiotic and registered Dermatology product brand registration documentation by:-

• amending registered detail, where applicable, after receipt of revised documentation from the respective GSK overseas divisions, third party contractors or due to in-house revisions.
• including new shelf-life and scheduling information.
• including updated specifications, methods, stability reports, comparative dissolution rate study data and bio-availability data (if applicable).
• ensuring Master Batch Records, Manufacturing Procedures and In-Process Controls are in compliance with registered documentation and GSK Product Standards.
• maintaining and updating OPAL in compliance with current registered detail
• Meets Department KPI targets.
• Communicates with MCC by:-
• liaising on registration matters and requirements for Anti-infectives product brands.
• notifying MCC as to amended registered detail.
• applying for extension of product shelf-life, formulation and presentation changes.
• applying for specific exemption from legislative requirements.
• undergoing pre-/post registration inspections.
• Ensures correctness of amendments to printed packaging components by:-
• checking against standards as per registered detail and noting errors
• checking format and content compliance with latest regulations and codes of conduct
• Checks and authorises changes to Master Documentation.
• Provides regulatory advice on all GSK company product brands in accordance with legal requirements and relevant codes of conduct.
• Communicates effectively with the relevant GSK central group personnel relating to GSK product brands in accordance with the therapeutic area of responsibility.
• Keeping abreast of developments and changes in the local regulatory environment which directly impacts on the GSK product brands.
• Reviews amendments to Master printed packaging components if precipitated by MCC requirements, regulations or requirements by the respective overseas divisions.
• Evaluates, checks and submits relevant typed stability test reports to MCC for approval.
• Updates the Product Information List and OPAL database.
• Checks and authorises BOM (Bill of Material) entries as aligned to therapeutic areas of responsibility.
• Checks Technical Terms of Supply (TTS) and Registered Technical Details (CMAC) for compliance with registered product details and authorises these from a regulatory perspective.
• Quarterly review of product brand authorisation data.
• Compiles a monthly life-cycle report reflecting:
• actual delivery on KPI targets
• all amendments processed with the MCC pertaining to the specific month
• the updated status on on-going projects
• proofs checked in conjunction with time allocated to each item
• summary of discussions of all meetings attended (in conjunction with time allocation)
• and forwards this at the end of each month to the Head of Regulatory Affairs via e-mail.

Knowledge

• Local laws and regulations relating to regulatory environment and pharmaceutical business including QMS requirements, GxP, manufacturing and testing.
• Regulatory
• Complexity:
• Managing all regulatory aspects of portfolio of product brands.
• Evaluating, determining the relevance of and processing product down scheduling with the MCC.
• Analysing and reporting of stability data.
• Evaluating, determining the relevance of and processing technical changes with the MCC.
• Independent Thinking: (Provide examples of innovations or creative approaches used and indicate the frequency with which they are performed. Indicate the degree to which this position is governed by procedures and standards).
• Present product brand support documentation in a manner to ensure first time MCC approval.
• The position is governed by GSK Standard Operating Procedures and the Codes of Conduct, Acts and Regulations.

Responsibility

• Support Commercial by obtaining regulatory approval and maintaining regulatory compliance for all product brands, line extensions, material source changes, etc. within the required approval timelines.
• Support QA, NPI, Procurement and Production Departments by providing regulatory requirements and advice for all product brands and processes.
• Communicate with the relevant GSK overseas regulatory personnel relating to GSK products in accordance with the therapeutic areas of responsibility and portfolio of product brands.

Contact Information

You may apply for this position online by selecting the Apply now button.

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