Regulatory Affairs Specialist - Drug

Our client, a dynamic and growing
** pharmaceutical company**, is seeking a highly competent Regulatory Affairs Specialist to join their team in
** Mahikeng, North West, ZA**. This crucial role will focus on preparing, submitting, and maintaining regulatory filings for new drug applications (NDAs) and variations across various international markets. You will be responsible for ensuring that all submissions are compliant with current global regulatory requirements and guidelines. This is a fully remote position, offering unparalleled flexibility and the opportunity to work from anywhere within South Africa.

The ideal candidate will possess a deep understanding of regulatory landscapes and a proven track record in managing complex regulatory projects within the
** pharmaceutical sector**. Your expertise will be vital in accelerating the approval and accessibility of our client's innovative medicines to patients worldwide.

Prepare, assemble, and submit regulatory dossiers for new drug applications (NDAs), generic drug applications (GDAs), and variations to health authorities globally (e.g., SAHPRA, FDA, EMA). Ensure compliance with relevant regulatory guidelines, such as ICH, FDA, and EMA regulations. Liaise with Health Authorities to respond to queries and facilitate the review process. Maintain regulatory submission timelines and track the status of applications.

Develop and implement regulatory strategies to support product development and lifecycle management. Review and approve labeling, promotional materials, and advertising to ensure regulatory compliance. Provide regulatory guidance and support to internal teams, including R&D, marketing, and clinical operations. Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies. Manage post-approval regulatory commitments and ensure ongoing compliance.

Contribute to the development and improvement of regulatory processes and SOPs.

Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field. A Master's degree or equivalent is preferred. Minimum of 4-6 years of experience in
** pharmaceutical regulatory affairs**. Proven experience in preparing and submitting various types of regulatory filings (e.g., NDAs, variations). In-depth knowledge of global regulatory requirements and guidelines (ICH, FDA, EMA, SAHPRA). Excellent understanding of drug development processes and
** pharmaceutical manufacturing**. Strong analytical and problem-solving skills with meticulous attention to detail. Exceptional written and verbal communication skills, including the ability to write clear and concise regulatory documents. Ability to work independently and manage multiple projects effectively in a remote setting. Proficiency in regulatory information management (RIM) systems and MS Office Suite. Experience in the
** pharmaceutical industry
** is essential.

• Competitive salary and potential for performance bonuses.
• Full remote work arrangement, offering excellent work-life balance.
• Comprehensive health and wellness benefits package.
• Opportunities for professional development and international exposure.
• Generous annual leave and paid sick leave.
• Contribution to a company committed to improving global health.
• Flexible working hours to accommodate individual needs.
• Be part of a forward-thinking
  ** pharmaceutical regulatory affairs
  ** team.