Job Purpose:
To compile and submit GSK product registration dossiers to the respective Southern Africa Regulatory Authority requirements and GSK standards and strategies as directed by the Regulatory Affairs NPI and Labelling Manager.
To compile and submit GSK product labelling changes to the respective Southern Africa Regulatory Authority requirements and GSK standards and strategies.
To provide regulatory support and product information to all GSK related functions, including tenders, and to keep abreast with regulatory developments in the Southern African regulatory environment for effective work execution and strategic planning

Essential Job Responsibilities:
1. Compile and submit GSK new product registration applications and labelling life-cycle management changes to the relevant requirements of the Regulatory Authorities in Southern Africa by:
- communicating with the respective global and commercial divisions with regard to registration matters;
- assembling the registration dossiers from product information received from respective global divisions;
- amending registered detail, where applicable, in compliance with GSK standards after receipt of revised support documentation from the respective global divisions;
- liasing with QA on specification and testing methods for locally manufactured and imported products, before product launch;
- maintaining and updating OPAL in compliance with current new product regulatory details.
- maintaining and updating databases and systems supporting business operations.
2. Communicates with the respective Regulatory Authorities in Southern Africa by:
- liaising on GSK NPI and labelling registration matters and requirements for the relevant therapeutic area GSK products;
- submitting newly compiled registration dossiers;
- undergoing Pre-/Post-registration inspections;
- notifying Authorities as to amended registered detail;
- applying for indication; scheduling and safety update changes.
3. Ensures correctness of amendments to printed packaging components and maintains Master printed packaging components.
4. Issues typed Artwork Master Document of printed packaging components for new product registrations or approved amendments if precipitated by requirements and regulations of Regulatory Authorities in Southern Africa or requirements by respective global divisions.
5. Follows change control for effective implementation of approved changes to registered detail.
6. Reviews and approves Advertising and Promotional material in the South African market in accordance with legal regulatory requirements and relevant Codes of Conduct.
7. Upon receipt, immediately e-mail all Regulatory Authority correspondence letters to the Regulatory NPI and Labelling Manager and copies the Head of Regulatory Affairs in the communication.
8. Communicates effectively with the relevant global group personnel relating to GSK product brands in accordance with therapeutic area of responsibility.
9. Keeps abreast of all developments and changes in the Southern African regulatory environment and incorporates these changes into agreed ways of working.
10. Advises on local regulatory requirements for both local and global projects.
11. Liaises and directs adverse event, compassionate use and medical information queries to relevant Departments.
12. Meets compliance and performance targets of global systems and databases e.g. OPAL; GRACE.
13. Compiles a Monthly Report for submission each month to the Regulatory Affairs NPI and Labelling Manager reflecting:
- all submissions processed with the respective Southern Africa Regulatory Authority
- updated status of all on-going projects
- all Advertising and Promotional material activities, in conjunction with time allocated to each item processed
- printed packaging component proofs checked in conjunction with time allocated to each item
- summary of discussions at meetings attended in conjunction with time allocation
- delivery against KPI targets
14. Provides input to Monthly and Quarterly Status Reports.


Qualifications: (List the education/training, experiences and skills/competencies.)
SCHOOL:
High School Certificate (Matric/Grade 12 or equivalent)

POST SCHOOL:
Tertiary: B.Pharm or equivalent

EXPERIENCE:
At least 3 years’ experience in a pharmaceutical product registration environment.

TRAINING:
GSK Standard Operating Procedures and Policies and the Codes of Conduct, Acts and Regulations
GSK Regulatory Curriculum