South Africa Job Openings

Virbac

Regulatory Affairs Manager

Centurion

FULL TIME

December 3, 2024

Experiencing together a unique human adventure

Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.

1. A pharmacist, responsible to SAPC for complying with all provisions of the pharmacy act, medicines act and other legislation applicable to services which specially pertain to the scope of practice of a pharmacist and the legislation applicable to the Virbac pharmacy which is under her personal supervision and who is registered as such in terms of the pharmacy act.
2. Responsible for RA department for RA Employees supervision, Maintenance of existing product marketing authorisations and Preparation of new submissions for registration both locally and in export countries, as well as compliance with local and foreign product regulatory submissions legislation relating to veterinary products and related activities.

Area of responsibility 1:

Main activities

1.1 LEGAL COMPLIANCE:

Licensing requirements - DOH; SAPC; SAHPRA
- Personal accountability
- Security, control & sale of medicines
- Compliance with Pharmacy legislation & Marketing Code

1.2 HUMAN RESOURCES:

Direct personal supervision
Delegation letters
Job Descriptions
Organogram
Appropriate knowledge & experience
Effective GMP Training

1.3 ETHICAL CONSIDERATIONS:

- Integrity – personal, data product- PV duties- ADR / AE

CPD- Reporting Company non-compliance- Recalls
Continuous Improvement

1.4 QUALITY MANAGEMENT SYSTEM:

- Control of manufacturing & distribution of medicines - SOP Training- Implementation of comprehensive QMS/ PQS requirements across the Company- Self-inspections and Audits- Contract Giver activities

1.5 REGULATORY COMPLIANCE:

Artwork & Labeling - Dossier submissions & maintenance - Supervision of all employed Pharmacists - Annual fees: Product, Pharmacy & Pharmacists - S5, S6 and Alcohol registers
Launches

Expected results

Ensure that the Virbac RSA Pharmacy is duly registered with DOH, SAPC, SAHPRA and all other required registrations e.g. Company’s Act. i.e. all required certificates and licenses of the pharmacy are in place and have not expired.

Lead auditee by external auditors SAPC, SHAPRA, other.

Personally accountable for the security, control and sale of medicines.

Ensure compliance and assume legal responsibility for compliance with all legislations & that Promotion of products does not violate the applicable codes and laws in place.

Ensure continuous personal supervision of the business of Virbac RSA Pharmacy by:

Only authorized personnel have access to medicines.

All authorized personnel have Job descriptions to stipulate the duties and responsibilities in line with the work they perform.

Ensure personnel working with products are GMP Trained.

Ensure that there are systems in place to provide for personnel integrity and data integrity pertaining to products.

Ensure there is a system in place for ADR and post marketing surveillance of products and that patient safety is monitored.

Report to the authorities any illegal activities that Virbac RSA may perform that are against the Pharmacy Act and Medicines Act.

Perform mock recalls and ensure that any products released that may endanger patients and users are recalled in line with set SOPs.

Review legislation and Guidelines to ensure that Virbac processes and products are continually of high quality and standards.

Ensure that a Virbac RSA has a Quality Management system in place and that required personnel are employed and trained in QMS.

Review and approve all Master documentation e.g. Quality Manual, Validation Master Plan, Cleaning Master Plan, SOPs. Ensure that there systems in place for personnel to adhere to Gx P.

Ensure there are systems in place for Internal Self-Inspections, Audits and Contracted activities.

Ensure that Virbac RSA products are manufactured and distributed in the right manner & that only approved customers receive the scheduled products.

To administer and make sure systems are in place for the regulatory compliance activities so that all Artwork, Advertising, Product Launches, Dossiers, and Scheduled substances are controlled as per the Medicines Act.

Ascertain that all employed Pharmacists and Pharmacists Assistants at Virbac RSA are duly registered with SAPC, Have CPD and are competent. All directors have signed Ethical rules compliance letters.

Ensure the Virbac RSA Pharmacy is registered with SAPC, SAHPRA and that annual fees thereof are paid. Ensure that Medicines Registers viz. S5, S6 are kept and controlled in line with the Medicines and Pharmacy Acts.

Area of responsibility 2: [REGULATORY AFFAIRS MANAGEMENT]

Main activities

OVERSIGHT OF NEW PRODUCT REGISTRATIONS & SUBMISSIONS TO REGULATORY AUTHORITIES (RSA & EXPORT)

Ensure timeous review, preparation, submission and follow-up of dossiers for both Act 36 and Act 101 as well in export countries by team.

Ensure artwork for new products is created timeously & compliance with legal and company requirements

Manage Innovation Hit list & review viable projects

OVERSIGHT OF EXISTING PRODUCT RETENTION, AMENDMENTS & SUBMISSIONS TO REGULATORY AUTHORITIES (RSA & EXPORT)

Ensure that existing registrations are maintained and amendments are submitted as required by the team. Ensure existing artwork is current and in compliance with legal and company requirements

Manage amendments in Innovation Hit list

REGULATORY STANDARDS & PROCESSES

Management of Master files and database, both hardcopy and electronically Regular reporting on regulatory status (internal). Create and maintain SOPs for RA processed

PEOPLE MANAGEMENT

Propose resource requirements and appropriate organisational structure to meet the strategic missions, critical success factors and business outcomes for the department

Manage and supports the recruitment of staff with the right experience, competencies and fit with the Virbac culture
Provide on-going feedback and coaching to direct reports in order to ensure they meet the expectations of performance, and to develop and support them in their role
Ensure the implementation of:-

proper performance definition (job description and objectives),
evaluation (regular feedback, annual performance review and other appropriate performance management measures),
reward and recognition and
training and development processes (Individual development plans as appropriate)

Ensure the communication and understanding of the company’s vision, values, culture and strategy, and fosters a positive, motivating working environment for all employees
Assist in the implementation of programs to improve employee and team performance, satisfaction and retention
Contribute to succession planning
Encourage and facilitates interdepartmental team work

Ensure the department proactively participates in all environmental, health and safety initiatives and complies with required policies and standards

2.5 FINANCE & BUDGET MANAGEMENT

Draw-up budget & operate within approved RA budget. Motivate for additional/replacement infrastructure to meet RA requirements as and when required

Manage expenses in line with the department budget Annual SPM Budget process

2.6 CUSTOMER & STAKEHOLDER RELATIONS

Maintain contact with Regulatory Authority & influencers Representative on RA Industry bodies Identify all stakeholders relevant to RA and registration processes.

Area of responsibility 3: [SENIOR MANAGEMENT for Virbac RSA].

Main activities

COMEX and LT Responsibilities

To fulfill the duties as prescribed for senior management personnel of Virbac South Africa. Meet monthly to focus on strategic development and operational execution

Report monthly on departmental KRA's in dashboard format, highlighting successes and challenges to business.

Recommend corrective action, where necessary

Monitor monthly progress in terms of execution of key strategies across company Provide key departmental input for inclusion in Virbac RSA SPM to CFO and local financial team

Identify KRA’s with GM and colleagues on leadership team Communicate with one voice from leadership team to rest of company

IBD Activities

Key member for the IBD process to make sure that the Business Development is in line with local Legislative requirements. Feasibility of the projects is assesses timeously in line with RSA and Export legislations and guidelines

Maintain Project status (Product Pipeline) in line with the existing Stage gate process.

Expected results

To achieve shared business objectives by leading a proactive and cohesive leadership team with aligned goals and communicating with one voice

Attend IBD Meetings to assess projects as presented by BUs.

Ensure that Approved dossiers are requested from the Country of origin and determine timelines of each project. Maintain and update the IBD Hit-List to make sure projects status visibility and expected next steps.

Virbac provides numerous career opportunities, thanks to the diversity of its jobs and their international dimension.

Joining Virbac means joining dynamic teams ambitious for success.

Add Your Talent to Ours!

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