Description

MAIN PURPOSE OF THE JOB:

Experienced Regulatory Affairs Pharmacist required for short term (3-month) contract to focus on and complete:

· Regulator Quality information Summary (QIS) and

· Quality Overall Summary (QoS) forms for Janssen registered products.

STRUCTURES: Reports to:

- Head of Regulatory Affairs

- Regulatory Affairs Pharmacist _ Therapeutic Area Leads

PRE-REQUISITES:

- Experienced Regulatory Affairs Pharmacist (5 years plus).

- Computer Literacy essential.

- Proficient in eCTD dossier format essential .

- Excellent written and verbal communication skills.

- Strong communication skills with key customers both internal and external (e.g. Global Regulatory Affairs, Regulatory Therapeutic Experts and Health Authorities)

- Uncompromising attention to detail and accuracy

- Ability to work independently in a high-pressurized environment.

KEY RESULT AREAS AND RELATED TASKS:

Accurate and timely completion of baseline QIS and QIS templates for Janssen Registered products, within the dedicated period.

To interact with Global Regulatory CMC and Regulatory Affairs – Therapeutic Area Experts to ensure the forms are completed compliantly.

Sourcing of data required using Company platforms and resources available.

Qualifications

COMPETENCIES

1. Knowledge of Health Authority requirements, Guidelines and The Medicines Act.

2. Knowledge of Foreign Registration Requirements (viz. Africa)

3. Knowledge of international requirements.

4. Understanding of departmental and company SOP’s.

5. Understanding of Janssen Global Regulatory Platforms ( a huge advantage due to timeline)

6. Proficient in Lotus Notes.

7. Analytical and detail orientated.

8. Planning and organization

9. Teamwork and co-operation