Job Description

POSITION SUMMARY

The Regulatory Affairs Pharmacist will compile, submit and track the regulatory submissions for the Zoetis 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.


EE Candidates Preferred.

POSITION 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 proffiency 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 Page 2 - 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

We are one Zoetis - 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