Regulatory Pharmacist at Pharma Dynamics (Pty) Ltd

Description

ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOW

Product registration

• Conduct due diligence on received change controls, variation packages, and dossiers pertinent to, but not restricted to, LCM of the assigned product portfolio.   
• Compilation of dossier modules related to submission of variations and/or SAHPRA responses when not supplied by third party stakeholders.
• Identify and maintain updates on registered products based on SAHPRA guidelines and allocated priorities.
• Assist in review and sign off of submissions compiled by Regulatory Scientists.
• Interact on a regular basis with PD departments, overseas affiliates, third parties and contractors on necessary regulatory activities.
• Liaise with SAHPRA on behalf of Pharma Dynamics on new and existing queries, as and when required.
• Compile and submit all responses to SAHPRA recommendations, Safety Updates and variations, within agreed and specified time limits.
• Maintain the department’s online apps (eg. CCP database, docuBridge, AW app etc) as per official SOPs and/or working instructions.
• Assistance with the artwork process to finalise printed packaging components in submitted countries in line with Act 101 and the Marketing Code.
• Supervise/manage/coach staff complement and related activities, if/when necessary

General

• Perform any other duties as per changes in operational requirements of the department.
• Perform any other duties as requested

Technical /Compliance activities

• Manage and monitor the Change Control Process effectively
• Liaise with SAHPRA on registration status and technical queries
• Assist with technical queries internally and with the guidance of line management, externally, as/when necessary.
• Assist with answering relevant Pharmacovigilance and Technical queries, as/when necessary.
• Assists with review and approval of batch release documents, as/when necessary.
• Assists with periodic internal audits, as/when necessary. 

Packaging material

• Review and facilitate approval of printed packaging components
• Ensure all printed material, complies with the Marketing Code of Conduct and SAHPRA requirements

Document management

• Ensure the EDMS is current and up to date and in line with submitted dossiers.

Requirements

PRE-REQUISITES

• B. Pharm registered with the SA Pharmacy Council
• Minimum of 2 – 3 years Regulatory hands-on experience, within the pharmaceutical industry.
• Able to perform all standard registration processes under specialist guidance

COMPETENCIES

Initiating Action and taking initiative: (Level 1-2 _ Operational / Tactical Lower)

• Demonstrates drive and energy in performing the job.
• Recognizes and acts on opportunities to address present problems and sees what needs to be done.
• Acts without being told or forced by events; is self-directed.
• Responds to situations or opportunities with appropriate sense of urgency.
• Works to achieve more than average results.
• Willing and eager to seek out and accept new challenges.

Resilience and Tenacity: (Level 3 – Tactical Higher)

• Tackles difficult and complex problems and takes personal responsibility and accountability for reaching solutions.
• Remains determined despite frequent obstacles.
• Maintains enthusiasm of others after disappointment or rejection.
• Bounces back very quickly.
• Leads others through dealing with disappointment/rejection.
• Re-engineers or creates new processes and systems to get around obstacles.
• Anticipates problems and proactively designs contingency plans.

Professional Knowledge and Skills (Level 3 _ Tactical Higher)

• Thorough understanding of the knowledge / skill area.
• Effectively applies a broad range of principles, practices and procedures in the knowledge / skill area.
• Is sought out by others for advice for the resolution of difficult problems.
• Can work independently.
• Keeps up with current developments in area of expertise.

Information Management: (Level 1 - 2_ Operational/ Tactical Lower)

• Aware of the knowledge and information relevant to their roles and the value this brings to the company.
• Reviews and communicates gaps in knowledge and information which hinder the achievement of objectives.
• Shares knowledge and information appropriately and participates in activities to facilitate sharing.
• Understands and complies with information management standards and guidelines.
• Effectively uses standard retrieval and distribution tools.
• Uses appropriate knowledge and information resources.
• Complies with information confidentiality and security standards.
• Contributes to the development of processes, tools and standards.

Written Communication: (Level 2 _ Tactical Lower)

• Organizes moderately complex written work that is clear and easy to follow.
• Writes in a manner that expresses the intention and achieves desired results.
• Uses vocabulary and sentence structure that is appropriate to the context and the audience.
• Develops and uses graphics, as appropriate, to convey content.

Analytical thinking/Problem Solving: (Level 2 _ Tactical Lower)

• Adjusts to work effectively within new work structures, processes, requirements, or cultures.
• Views change as an opportunity to improve.
• Willing and eager to change.
• Actively seeks out positive spin-offs of change and investigates ways in which change can be used.
• Anticipates change and continuously remains prepared for change.
• Demonstrates resourcefulness in acquiring necessary knowledge, skills and competencies to adapt to change.

Planning and organizing/ Work Management: (Level 2 _ Tactical Lower)

• Plans and implements moderately complex activities/projects.
• Clearly defines objectives and translates them into workable activities.
• Plans with a realistic sense of the time and resource demands involved maintaining awareness of the interrelationships between own and other activities/project.
• Anticipates potential obstacles and their impact on the accomplishment of goals and timelines.
• Uses time and resources effectively to accomplish desired results.
• Monitors and tracks progress to ensure delivery of all planned commitments, and keeps the appropriate people informed.

Results focus: (Level 2 _ Tactical Lower)

• Puts in extra effort (above what would normally be required) to accomplish a goal.
• Takes on-going, repeated action to overcome obstacles to goal achievement.
• Looks for and identifies better, faster, less expensive, or more efficient ways to achieve results.
• Continuously monitors progress towards goal achievements and acts decisively when progress is stalling.
• Willingly take on difficult assignments.