Regulatory Affairs Pharmacist GER Johannesburg South Africa RAPharm-1502

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.

POSITION RESPONSIBILITIES

• To compile and submit registration dossiers in accordance with the country specific requirements to relevant Regulatory Authorities in Southern Africa.

• Dossier Maintenance: Submission of post registration variations in line with country specific regulatory requirements.

• Submission of updated product Package insert or labelling updates in line with the country specific requirements and in line with the internal requirements.

• To maintain the relevant Global and local Regulatory and compliance databases.

• To align regulatory product registration submission strategy to commercial product strategy.

• Manage and develop strategies that overcome regulatory challenges for new product registrations and line extensions.

• Review of promotional materials to ensure adherence to country specific requirements.

• Maintenance of all relevant regulatory databases/systems within required timeframes.

• Regular interactions with local GSC&L colleagues to ensure continuous supply of products, utilizing regulatory knowledge to minimize any product out-of-stocks.

• Obtain necessary import permits (e.g., vaccine licenses, controlled drugs, non-authorized products).

• Regular interactions with country marketing/technical colleagues in advance of new product launches to ensure all relevant information is shared accordingly.

• Approval of new marketing material (detail aids, datasheets, advertisements) to ensure compliance with the MA and any applicable national requirements/advertising laws.

• Work with country colleagues to identify any product development opportunities.

• Build strong relationships with regulatory agencies to benefit Zoetis.

• Maintain a high degree of regulatory knowledge and monitor any ongoing legislative changes.

• Involvement with national trade associations, representing Zoetis to enable the company to lead in relevant developments.

• Assist the sales team with customer visits to explain regulatory requirements where required. Key Performance Areas

• Evaluation, Compilation and submission of accurate registration application and dossier amendments to Southern Africa Regulatory Authorities, in accordance with established formats.

• Maintenance of registration dossiers including submission of renewals in the relevant markets.

• Submission of labelling updates in line with the timelines and country specific requirements.

• Evaluation of artwork and initiation of artwork changes where relevant.

• Review of promotional material in accordance with relevant Promotional and Marketing Codes

• Liaising with the Regulatory Authorities in Southern Africa.

EDUCATION AND EXPERIENCE

• B.Pharm Degree or equivalent

• Registered with the South African Pharmacy Council (SAPC)

• At least 5 years’ experience in a pharmaceutical regulatory environment

• Experience with dossier compilation and submissions.

• Experience in Animal Health will be an advantage.

• In-depth knowledge of regulatory guidelines (SAHPRA regulations, GxP (Good Practice guidelines, and relevant laws governing pharmaceuticals)

TECHNICAL SKILLS REQUIREMENTS

• Strong Analytical skills

• Documentation management.

• Proficiency in MS Office Suite.

• Excellent written and verbal communication in English.

BEHAVIOURAL SKILLS AND ATTRIBUTES

• Strong communication and interpersonal skills.

• Attention to details.

• Teamplayer

• High level of ethical integrity and accountability.

• Strong problem solving and analytical skills.

• Detail orientation.

PHYSICAL POSITION REQUIREMENTS

• Ability to drive and travel locally and internationally if required.

• May be requested to work extended hours and weekends for special program events and/or trainin