Regulatory Affairs Specialist

What you'll do:

As a Regulatory Affairs Specialist, you will play an integral role in supporting the organisation’s mission of maintaining the highest standards of regulatory compliance and quality assurance. Your day-to-day activities will involve close interaction with both internal teams and external authorities as you coordinate document submissions, oversee licensing processes, manage detailed records, prepare essential product materials, and provide expert guidance on compliance matters. You will also be instrumental in supporting marketing launches by supplying critical registration data while assisting technical teams with product specifications. Success in this role requires not only meticulous attention to detail but also strong interpersonal skills that enable you to foster positive relationships across departments and with key stakeholders. By contributing your expertise in documentation management, process coordination, and regulatory oversight, you will help ensure that every product meets stringent quality standards before reaching the market.

• Maintain harmonious professional relationships with government regulatory agencies by communicating regularly and effectively on all matters related to product registration and compliance.
• Secure required documents from global affiliates, local research teams, and other stakeholders to facilitate timely local registration of products for line extensions, reformulations, new sourcing initiatives, and shelf-life extensions.
• Organise and manage a secure filing system for all pharmaceutical regulatory affairs documentation, ensuring easy retrieval and strict confidentiality at all times.
• Obtain and renew necessary government licenses, product registrations, and permits to ensure legitimate operations as importer, distributor, trader, or exporter within the region.
• Coordinate closely with internal teams such as Artwork Coordinators to review product literature, labels, packaging components, and artwork preparation in accordance with regulatory requirements.
• Collaborate with technical colleagues to provide prompt responses on pharmacovigilance reports and feedbacks while managing proper documentation for change notifications.
• Prepare artwork for products including labels, package inserts, and commercial facsimile presentations as per relevant authority requirements.
• Support marketing colleagues by providing up-to-date information on new products for market authorisation requests (MAR), approval processes, and estimated launch dates.
• Assist technical service managers with accurate product information and specifications as needed for various projects or client queries.
• Evaluate product registration dossiers for product releases to ensure all regulatory commitments are met prior to commercialisation.

What you bring:

To excel as a Regulatory Affairs Specialist in this organisation, you will bring proven experience from similar roles where you have demonstrated reliability in managing complex documentation processes under strict deadlines. Your educational background equips you with the foundational knowledge needed to interpret intricate regulations while your hands-on experience ensures practical application of these standards. You possess excellent communication abilities that foster trust among colleagues and external partners alike. Your proficiency with digital tools streamlines administrative tasks so that nothing falls through the cracks. Furthermore, your willingness to participate in ongoing training reflects your dedication to continuous improvement—both personally and professionally. By combining technical acumen with empathy-driven collaboration skills, you will thrive within this supportive team environment.

• A graduate degree from a four-year college or higher education institution is required; preference will be given to those with backgrounds in Veterinary Science, Pharmacy or Paramedical fields due to their relevance in understanding complex regulatory frameworks.
• At least two years’ experience working within regulatory affairs or quality assurance roles is essential; candidates with exposure to the pharmaceutical or veterinary industries will be particularly well-suited for this position.
• Active participation or affiliation with industry associations or government/regulatory bodies demonstrates your commitment to staying current with evolving standards and best practices.
• Excellent interpersonal skills are vital as you will need to collaborate effectively with colleagues at all levels as well as external agencies such as FDA or BAI.
• Strong decision-making abilities combined with sound problem-solving skills enable you to navigate complex situations while maintaining compliance at all times.
• Outstanding verbal and written communication skills allow you to articulate technical information clearly when liaising with authorities or preparing documentation.
• Proficiency in using personal computers—including word processing software, spreadsheets, databases—is necessary for efficient document management and reporting tasks.
• A keen eye for detail ensures accuracy in record-keeping while upholding high standards of quality work throughout all aspects of the role.
• Experience conducting training sessions on quality systems implementation is advantageous as it supports knowledge transfer within the team environment.

What sets this company apart:

This organisation stands out for its unwavering commitment to upholding the highest standards of regulatory compliance while nurturing an inclusive workplace culture built on mutual respect and shared success. Employees benefit from access to comprehensive training programmes designed not only to enhance technical expertise but also promote holistic personal development. The company places great emphasis on open communication channels—ensuring everyone’s voice is heard—and fosters an atmosphere where teamwork flourishes naturally. Flexible working arrangements further support work-life balance so that staff can perform at their best without compromising wellbeing. With a reputation for ethical business practices backed by robust support structures at every level of the organisation, joining this team means becoming part of a community dedicated not just to professional achievement but also collective growth.

What's next:

If you are ready to take the next step in your career journey within regulatory affairs—where your expertise will truly matter—this is your chance!

Apply today by clicking on the link provided; we look forward to learning more about how your unique skills can contribute to our continued success.