Senior Regulatory Affairs Specialist; Pharmaceuticals

About the Role Our client, a prominent pharmaceutical company, is actively seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to join their team in
** Nelspruit**. This crucial role will involve managing and coordinating regulatory activities to ensure compliance with national and international pharmaceutical regulations. The successful candidate will play a vital part in bringing innovative medicines to market by navigating complex regulatory landscapes. This position offers an excellent opportunity for professional growth within a supportive and dynamic corporate culture in the
** Mpumalanga
* * region. As part of a dedicated team, you will contribute significantly to the company's mission of improving patient lives through accessible and high-quality pharmaceuticals. The hybrid work model provides a flexible approach, blending essential in-office collaboration with the convenience of remote work, fostering a productive and balanced work environment.

• Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals in accordance with relevant health authority requirements (e.g., SAHPRA, FDA, EMA).
• Liaise with regulatory agencies, health authorities, and internal stakeholders to address queries and facilitate the approval process.
• Monitor changes in pharmaceutical regulations and guidelines and assess their impact on company products and processes.
• Develop regulatory strategies for new product development and lifecycle management.
• Ensure compliance with labeling requirements, advertising, and promotional materials.
• Provide regulatory guidance and support to other departments, including R&D, marketing, and quality assurance.
• Conduct regulatory intelligence gathering and analysis to identify potential opportunities and risks.
• Manage post-approval commitments and ensure ongoing compliance for marketed products.
• Participate in regulatory audits and inspections.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• A Master's degree or equivalent experience is preferred.
• Minimum of 5-7 years of experience in pharmaceutical regulatory affairs, with a strong understanding of the drug development and registration process.
• Proven experience in preparing and submitting dossiers to regulatory authorities, particularly SAHPRA.
• In-depth knowledge of pharmaceutical regulations, guidelines, and submission requirements (e.g., CTD format).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to manage multiple projects simultaneously and meet strict deadlines.
• Strong analytical and problem-solving skills.
• Proficiency in regulatory information management systems is a plus.
• Experience working within the
  ** Nelspruit
  * * area or a willingness to relocate is required.

• Competitive salary commensurate with experience.
• Comprehensive health, dental, and vision insurance plans.
• Retirement fund contributions.
• Opportunities for continuous professional development and training.
• A collaborative and supportive work environment focused on innovation.
• Flexible working hours and a hybrid work model.
• Paid annual leave and public holidays.