Regulatory Affairs Pharmacist Job at GlaxoSmithKline (GSK)
Job Purpose/Scope
To achieve registration of new products and, line extensions and new indications (responsibility of commercial focus regulatory group) for Consumer Health Care Products. Maintain existing registration dossiers effectively in accordance with the requirement of the MCC,
NMRC, DRU, MOZ, ZAM, Malawi and Angola regulatory authorities. Maintaining regulatory and quality compliance for non-registered products including Nutritionals in South Africa and the export markets.
Job Title: Regulatory Affairs Pharmacist
Location - Town / City: Johannesburg
Location - Country: South Africa
Reporting To: Head of Regulatory-Consumer Health
Type of position: Permanent
Location - Country: South Africa
Reporting To: Head of Regulatory-Consumer Health
Type of position: Permanent
Key Responsibilities
- Evaluation of registration documents received from overseas and local sources for completeness and suitability, and to liaise with them accordingly.
- Compilation of registration files and support data for new products, indications and line extensions for Consumer Health products, for submission to and approval by the respective Regulatory Authority.
- Following-up on feedback and requirements from the Regulatory Authority by obtaining further data locally or overseas
- Amending and updating package inserts and packaging artwork in line with basic text and respective Regulatory Authority requirements and ensuring compliance with the approved registered details.
- Maintaining of proper records of all correspondence, applications, etc. relevant to registration
- Liaising with GMS with regard to regulatory changes affecting registered details in all Southern Africa markets as well as Cosmetics and Nutritionals.
- Liaising with all Regulatory Authorities where Consumer Health products are marketed.
- Evaluation of present, past and future health legislation to ascertain how GSK Consumer Healthcare is affected and whether such legislation is being fully complied with by GSK Consumer Healthcare
Qualifications, Experience
- A tertiary qualification in Life Sciences and/or a Qualification in pharmacy
- International experience is preferable due to the global nature of the Consumer Healthcare brands involved.
- A minimum of 2 years experience in a pharmaceutical regulatory environment
- Competencies
- Understanding of the Southern Africa regulatory environment and
- Understanding of the principles of marketing and sales in the Consumer business environment
- Communication and inter-personal skills.
- In depth understanding of the ASA code, Marketing Code and Cosmetic market.
- Good understanding of the Southern Africa Regulatory Authority workings and relationship
- Ability to work well under pressure and still maintain sound balance in decision making
- Ability to quickly change the strategy according to the regulatory environmental requirements and market dynamics.
- Ability to meet the deadlines for the strategic and tactical plans.
Method of Application
Interested candidates should Click here to apply online
Application Deadline: July 31, 2012
Don't miss Jobs like this. Subscribe to our Jobs Alert if you have not. Its free. CLICK HERE NOW
Also Like our Facebook Fan Page here www.facebook.com/naijajobsportal
Don't miss Jobs like this. Subscribe to our Jobs Alert if you have not. Its free. CLICK HERE NOW
Also Like our Facebook Fan Page here www.facebook.com/naijajobsportal
Subscribe to:
Post Comments
(
Atom
)
No comments :
Post a Comment