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Title
Text copied to clipboard!Specialist Regulatory Affairs Pharma
Description
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We are looking for a Specialist Regulatory Affairs Pharma to join our team and ensure that our pharmaceutical products comply with all relevant regulations and guidelines. In this role, you will be responsible for preparing and submitting regulatory documents, liaising with regulatory authorities, and providing strategic advice to ensure successful product registrations. You will work closely with cross-functional teams, including research and development, quality assurance, and marketing, to ensure that all regulatory requirements are met throughout the product lifecycle. The ideal candidate will have a strong understanding of pharmaceutical regulations, excellent communication skills, and the ability to manage multiple projects simultaneously. You will play a critical role in ensuring that our products are safe, effective, and compliant with all applicable laws and regulations. If you are detail-oriented, proactive, and passionate about regulatory affairs, we would love to hear from you.
Responsibilities
Text copied to clipboard!- Prepare and submit regulatory documents to authorities.
- Ensure compliance with pharmaceutical regulations and guidelines.
- Provide strategic advice on regulatory matters.
- Liaise with regulatory authorities and stakeholders.
- Monitor changes in regulations and update internal processes.
- Collaborate with cross-functional teams to ensure compliance.
- Manage regulatory submissions and approvals.
- Maintain regulatory documentation and records.
Requirements
Text copied to clipboard!- Bachelor's degree in pharmacy, life sciences, or related field.
- Experience in regulatory affairs within the pharmaceutical industry.
- Strong understanding of pharmaceutical regulations and guidelines.
- Excellent communication and interpersonal skills.
- Ability to manage multiple projects and deadlines.
- Detail-oriented with strong organizational skills.
- Proficiency in regulatory submission software.
- Ability to work independently and as part of a team.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with regulatory submissions?
- How do you stay updated on changes in pharmaceutical regulations?
- Describe a challenging regulatory issue you have faced and how you resolved it.
- How do you prioritize tasks when managing multiple projects?
- What strategies do you use to ensure compliance with regulations?
