About the position
SUMMARY
The Regulatory Affairs Pharmacist will compile, submit and track the regulatory submissions for the clients product portfolio and ensure compliance with the related Acts and guidelines of each territory and includes registration, pre-approval and post-approval activities. Monitoring and reviewing project progress on an ongoing basis. Ensuring the timely completion of responsibilities and activities in line with the business goals.
RESPONSIBILITIES
Evaluation, compilation and submission of accurate new product applications and post registration dossier amendments to SAHPRA and African Regulatory Authorities, in accordance with established and current formats and requirements.
Maintenance of registration dossiers in compliance with regulatory requirements, including submission of renewals in South Africa and across Africa.
Submission of labelling updates in line with the timelines and country specific requirements.
Evaluation of artwork changes and initiation of artwork.
Review of promotional material in accordance with relevant Promotional and Marketing Codes.
Liaising with SAHPRA & the Regulatory Authorities in Africa (English speaking).
To act as Deputy Responsible Pharmacist in the absence of the Responsible Pharmacist when required.
EDUCATION AND EXPERIENCE
B. Pharm Degree
Pharmacist registered with the South African Pharmacy Council.
5 years’ experience in a South African pharmaceutical regulatory affairs environment
Advantage: Biological product submissions across the African region
Previous Animal Health industry experience would be an advantage
TECHNICAL AND BEHAVIORAL SKILLS REQUIREMENTS
Key Skills:
Strong Communication and interpersonal skills.
Ability to operate as part of a strategic/operational team.
Comprehensive knowledge of the industry process.
Strong problem solving and analytical skills.
MS Suite proficiency
Behaviors:
Drive your team’s ongoing learning - keep their selling skills sharp
Be an ambassador for our solutions – know them inside and out, and continue to learn
Harness the momentum from success and the learnings from failure. Use it to drive the team forward
Always do the right thing
Promote a culture of doing right by the customer; sell responsibly and respectfully
Help build the reputation of our brand by understanding and supporting the things that we stand for
Customer obsessed
Encourage detailed and genuine interest and respect for the businesses of our customers
Establish effective and lasting relationships with customers that build loyalty to our brand
Run it like you own it
Focus yourself, focus the team on commercial success.
Always find every opportunity for incremental improvement – in sales performance, in behaviors, in processes, systems and ways of working
Develop motivated, positive and empowered individuals and bring them together in a high performing team
Empower decision making in others. Unlock the potential that exists in the team and grow it
Give the team timely information and support that helps them to deliver their role
PHYSICAL POSITION REQUIREMENTS
Ability to drive and travel locally and internationally if required
Own vehicle
Desired Skills:
- Dispensing (Medical)
- Management
- Medical
- Medical Assistance
- Medical Nutrition Therapy
- Medical Sales
- Medication Administration
