As a Regulatory Affairs Specialist, you will create regulatory submissions, develop strategies, and guide business unit regulatory teams. You will represent the company’s regulatory function on manufacturing and product development teams, providing input on regulatory requirements, alternatives for meeting those requirements, and resolving conflicts. You will also assess the impact of proposed and current global regulations and suggest ways to expedite approvals. This role requires excellent judgment, strong communication skills, and knowledge of registration requirements. Apply now to join our client’s dynamic team!
At DNA Recruitment, we carefully review all applications and aim to contact every suitable candidate within max. 5 working days. If you don’t hear from us, please consider your application unsuccessful on this occasion.
- Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by the company’s affiliates; track timelines and document milestone achievements; participate in developing regulatory strategy; prioritize submissions with operations plans.
- Participate in guiding strategies and contingency planning concerning the company’s regulatory requirements, including assessing the impact of proposed and current global regulations and proposing suggestions for expediting approvals.
- Participate in representing the company’s regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements, resolving conflicts between those requirements and development issues, and/or reporting to management.
- Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review labeling content and guidance on process improvement projects based on prior experience and responses from affiliates.
Qualifications & Skills
- Pharmacy Degree
- Saudi National 🇸🇦
- 3-5 years of experience in registering medical devices in KSA
- Experience in preparing domestic and international product submissions
- Proven expertise in Microsoft Office Suite, including Word, PowerPoint, and Excel
- Good written and verbal communication skills and interpersonal relationship skills
- Good problem-solving, organizational, analytical, and critical thinking skills.
- Solid knowledge and understanding of global regulations relevant to medical devices
- Strict attention to details
- Ability to interact professionally with all organizational levels
- Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
DNA consultant in charge of this requisition:
CEEMEA Junior Research Consultant