
Expert Regulatory Affairs Professional
16 hours ago
Regulatory Affairs Expertise for Drug Manufacturing
In this pivotal role, we seek a seasoned Regulatory Affairs Executive to spearhead product registrations with various health authorities.
The successful candidate will be responsible for compiling comprehensive Drug Master Files, meticulously preparing and submitting registration dossiers, technical data packages, and open parts.
Key responsibilities include ensuring in-house developed APIs are manufactured at designated sites, updating records accordingly, and responding to deficiency letters from regulatory agencies in a timely manner.
Additionally, the chosen candidate will craft regulatory amendments and variations to facilitate seamless API supplies, provide cross-functional support, reposition regulatory databases, and maintain compliance with established procedures.
If you possess excellent communication skills, attention to detail, and a keen understanding of regulatory frameworks, we encourage you to apply for this exciting opportunity.
Job Requirements:
- Extensive knowledge of regulatory affairs principles and practices.
- Excellent analytical and problem-solving skills.
- Strong communication and interpersonal abilities.
- Able to work effectively in a fast-paced environment.
- Opportunity to work with a reputable organization.
- Competitive salary and benefits package.
- Chance to grow professionally and expand expertise.
Please submit your resume and cover letter to us by email or online application form. We look forward to hearing from you
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