Senior Regulatory Affairs Specialist

Job Reference: 31886-Senior Regulatory Affairs Specialist
Company: RecruitArab - recruiter
Industry: Pharmaceuticals
Job Title: Senior Regulatory Affairs Specialist

Location: Dubai, UAE

Job Type: Full-Time

Closing Date: 2024-09-20

Email for Applications: apply@emiratesrecruiter.com

Position Overview:

We are seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to join our dynamic team in Dubai. The ideal candidate will possess extensive knowledge of pharmaceutical regulations and a proven track record in managing regulatory submissions and compliance for pharmaceutical products. This role is critical in ensuring that our products meet all local and international regulatory requirements, enabling us to deliver safe and effective medications to patients.

Key Responsibilities:

- Lead the preparation and submission of regulatory documents, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and variations to existing products in compliance with UAE and GCC regulations.
- Develop and implement regulatory strategies for product development, ensuring alignment with corporate objectives and timelines.
- Collaborate with cross-functional teams, including research and development, quality assurance, and marketing, to provide regulatory guidance and support throughout the product lifecycle.
- Monitor and interpret changes in regulatory policies and guidelines, providing timely updates and training to internal stakeholders.
- Liaise with regulatory authorities and act as the primary contact for all regulatory inquiries and inspections.
- Conduct thorough reviews of product labeling, promotional materials, and clinical trial protocols to ensure compliance with regulatory standards.
- Prepare and manage meetings with regulatory agencies to discuss submissions, product approvals, and compliance issues.
- Maintain a comprehensive regulatory database, ensuring all submissions and correspondence are accurately recorded and tracked.
- Provide mentorship and training to junior regulatory affairs staff, fostering a culture of compliance and excellence within the team.

Qualifications:

- Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree (Master’s/PhD) is a plus.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry, with a strong understanding of UAE and GCC regulatory frameworks.
- Proven experience in leading regulatory submissions and managing interactions with health authorities.
- Strong analytical skills with the ability to interpret complex regulations and guidelines.
- Excellent written and verbal communication skills in English; proficiency in Arabic is an advantage.
- Ability to work effectively in a fast-paced environment and manage multiple projects simultaneously.
- Strong attention to detail and problem-solving skills.
- Proficiency in regulatory databases and submission management tools.

What We Offer:

- Competitive salary and benefits package.
- Opportunities for professional development and career advancement.
- A collaborative and innovative work environment.
- The chance to contribute to meaningful projects that improve patient outcomes.

If you are passionate about regulatory affairs and ready to take your career to the next level, we encourage you to apply for this exciting opportunity.

To Apply:

Please submit your resume and a cover letter detailing your relevant experience and qualifications to apply@emiratesrecruiter.com by 2024-09-20. We look forward to hearing from you!


Please inculde this job reference [31886-Senior Regulatory Affairs Specialist] in the email when you send your application.

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