Regulatory Affairs Specialist (Fixed Term)

The REGULATORY AFFAIRS SPECIALIST is responsible for ensuring compliance with regulatory requirements, preparing and submitting regulatory documentation, maintaining reporting schedules, and providing solutions to regulatory challenges. You will support regulatory activities, communicate with agencies, and assist in compiling reports and correspondence to meet company objectives:  

Key Responsibilities 

• Innovate and streamline regulatory submission processes to accelerate product approvals while ensuring full compliance with global standards, including coordinating and compiling submissions for new drug applications, abbreviated new drug applications, and investigational new drug applications. 

• Collaborate cross-functionally with R&D, quality assurance, marketing teams, and other stakeholders to anticipate regulatory challenges, embed compliance into product development cycles, and communicate regulatory status updates clearly and professionally. 

• Develop and maintain a dynamic regulatory intelligence system to proactively monitor and interpret evolving regulations impacting the industry, and update global, regional, and local regulatory databases to ensure data integrity and compliance. 

• Craft and contribute to compelling regulatory strategies that balance risk management with business objectives, facilitate smoother market entry, and enhance department efficiency and compliance. 

• Lead the preparation, review, and organization of complex regulatory documents, including outlines, summaries, status reports, memos, visual aids, and responses to regulatory agency inquiries, ensuring accuracy, clarity, and alignment with local and international frameworks. 

• Support regulatory activities by providing solutions to moderately complex problems, ensuring quality and compliance in all regulatory processes, and assisting in reviewing and approving promotional materials and artwork to ensure regulatory compliance. 

• Interact effectively with regulatory agency personnel to facilitate guidance, expedite approvals, and resolve regulatory issues under supervision. 

What we are looking for 

Required Qualifications 

• Bachelor's degree or equivalent in a relevant scientific or related field 

• 2-4 years of experience in regulatory affairs or related roles 

• Proven experience managing regulatory data for regulated products including OTC drugs, cosmetics, and medical devices 

• Strong proficiency in Microsoft Word, Excel, PowerPoint, email, and internet research tools 

• Exceptional attention to detail with excellent documentation and organizational skills 

• Advanced English Level C1 

Desired Qualifications 

• Passion for navigating complex regulatory landscapes and driving compliance innovation 

• Strong analytical mindset with ability to interpret and translate regulatory guidelines into actionable business strategies 

• Familiarity with regulatory processes such as Drug Listing, IDMP, and Periodic Safety Reporting 

• Exceptional communication skills to articulate regulatory concepts clearly to diverse stakeholders and influence decision-making 

• Effective interpersonal and communication skills with a collaborative, team-oriented approach focused on delivering solutions 

• Ability to manage multiple tasks efficiently and maintain high-quality output under pressure 

• Adaptability in interpersonal styles and techniques to gain stakeholder acceptance and incorporate feedback constructively 

• Proactive learner committed to staying ahead of regulatory trends and leveraging new knowledge to enhance organizational compliance 

What’s in it for you    

• Competitive Benefit Package*          

• Paid Company Holidays, Paid Vacation, Volunteer Time & More!          

• Learning & Development Opportunities          

• Kenvuer Impact Networks          

• This list could vary based on location/region