Regulatory Affairs Clinical Trials
2 weeks ago
**Job Title: Regulatory Affairs Clinical Trials Pharmacist/Specialist**
**Business Unit/Division**:Regulatory Affairs
**Job Type Classification**:Permanent
**Location - Town/City**:Sandton
**Location - Province**:Gauteng
**Location - Country**:South Africa
**Key Performance Outputs**:
- Enhancing and managing relationships with regulatory health authorities (HAs) and Boards of Health (BoHs).
- Understand local regulations, guidelines and developing trends in the local regulatory environment. Leverage regulatory knowledge to anticipate barriers and recommend alternative approaches in line with local policies and procedures.
- Liaise with clinical research project managers and local clinical oversight colleagues to seek to understand clinical research programmes as required. Assist as applicable with any regulatory related country feasibility questions and regulatory intelligence.
- Participation in discussions with local clinical trial colleagues, clinical research organisations and clinical trial managers in order to respond timeously to Regulatory Authority queries.
- Co-ordination of meetings with the Regulatory Authorities to discuss clinical recommendations or any other clinical related matters, together, as required with the local and global clinical trial colleagues.
- Submission of two weekly and/or six weekly progress reports to Boards of Health and/or Ethics Committees for all ongoing clinical studies and end of study notifications as applicable.
- Ensure timely communication of any GCP breaches, or actions taken for safety reasons as required.
- Responsible for the co-ordination of regulatory activities associated with CTA submissions, including the development and submission of responses to HA queries and requests, and monitoring and following-up on progress of CTA submissions at the HA.
- Ensure compliance with local regulations, corporate regulatory processes, SOP’s and systems.
- Maintain compliance in company-specific regulatory systems, databases and local regulatory drive to ensure a state of audit readiness.
- Participate in internal audits as required.
- Represent regulatory affairs at CTA meetings as applicable.
- Where required, represent company at the relevant industry trade association meetings.
**Reporting Structure**:Regulatory Affairs Manager, Clinical trials
**Minimum Requirements**:
Bachelor of Science degree/Bachelor of Pharmacy degree
Demonstrable experience across the product development, commercialization and maintenance lifecycle
Proven ability to manage complex regulatory issues
Proven ability to consistently deliver to time, cost and quality standards
**Technical Skills**:
- In-depth knowledge of new and emerging Acts, Regulations and guidelines pertaining to the pharmaceutical industry.
- Knowledge of clinical trial methodologies ICH/GCP, FDA and local country regulations whilst useful is not critical.
- Knowledge of clinical trial and regulatory requirements as pertaining to human medicines.
**Behavioural skills and**
**Attributes**:Strategic thinker
Strong communication skills
Negotiation skills
Problem-solving abilities
Strong detail, quality and compliance orientation
Ability to understand stakeholder needs
Building strong peer relationships
Team player
Interpersonal acumen
‘Big-picture’ thinking
Analytical thinking
Change agility/adaptability
Ability to work under tight deadlines and with multiple conflicting priorities
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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