RA Pharmacist and African Distributor Markets

MNA Recruitment (Pty) Ltd; Gauteng; On-site; ZAR 200 000 - 300 000; Full time

Job summary

An exciting opportunity with a leading Animal Health Company in South Africa for an RA Pharmacist. You will be responsible for managing regulatory submissions and ensuring compliance for product lines across South African and African markets. Candidates should hold a B. Pharm degree and be a registered pharmacist. A minimum of 5 years' experience in pharmaceutical regulatory affairs is mandatory. Familiarity with biological submissions and the Animal Health industry is a plus.

Qualifications

• 5 years’ experience in South African pharmaceutical regulatory affairs.
• Experience with biological product submissions across Africa is an advantage.
• Previous Animal Health industry experience is a bonus.

Responsibilities

• Compile and submit regulatory submissions for product portfolio.
• Ensure compliance with regulatory Acts and guidelines.
• Evaluate and submit new product applications to SAHPRA.

Skills

Strong Communication and interpersonal skills

Ability to operate as part of a team

Comprehensive knowledge of the industry process

Strong problem solving and analytical skills

MS Suite proficiency

Education

B. Pharm Degree

Registered pharmacist with the South African Pharmacy Council

Experience in pharmaceutical regulatory affairs

Job description

Overview

A leading Animal Health Company has a vacancy for an RA Pharmacist to be responsible for the SA and African Distributor markets.

Job Purpose: The Regulatory Affairs Pharmacist will compile, submit and track the regulatory submissions for the 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.

Key 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

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

Behaviours

• Our Colleagues make the difference
• 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 behaviours, in processes, systems and ways of working
• Develop motivated, positive and empowered individuals and bring them together in a high performing team

Candidates that meet the criteria may apply via this portal or via www.mnarecruitment.com

Should you not receive feedback within 7 days, please accept your application as unsuccessful