Text copied to clipboard!
Title
Text copied to clipboard!Regulatory Affairs Specialist Pharma
Description
Text copied to clipboard!
We are looking for a Regulatory Affairs Specialist Pharma to join our team and ensure that our pharmaceutical products comply with all applicable regulatory requirements. In this role, you will be responsible for preparing, reviewing, and submitting documentation to regulatory agencies, monitoring changes in regulations, and advising internal teams on compliance matters. You will collaborate closely with research and development, quality assurance, and manufacturing departments to ensure that all products meet local, national, and international standards. 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 key role in product registrations, renewals, and variations, as well as in responding to regulatory queries and audits. Your expertise will help guide the company through the complex landscape of pharmaceutical compliance, ensuring that our products reach the market efficiently and safely. This position requires attention to detail, analytical thinking, and a proactive approach to problem-solving. If you are passionate about regulatory affairs and want to contribute to the success of a dynamic pharmaceutical company, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Prepare and submit regulatory documents to authorities
- Monitor and interpret regulatory changes affecting pharmaceuticals
- Advise internal teams on compliance requirements
- Coordinate product registrations, renewals, and variations
- Respond to regulatory agency queries and audits
- Maintain up-to-date knowledge of relevant laws and guidelines
- Collaborate with R&D, QA, and manufacturing teams
- Ensure timely approval of new products and updates
- Review product labeling and promotional materials for compliance
- Support internal and external audits
Requirements
Text copied to clipboard!- Bachelor’s degree in pharmacy, life sciences, or related field
- Experience in regulatory affairs within the pharmaceutical industry
- Strong knowledge of local and international pharmaceutical regulations
- Excellent written and verbal communication skills
- Attention to detail and organizational skills
- Ability to manage multiple projects simultaneously
- Proficiency in regulatory submission systems
- Problem-solving and analytical thinking
- Ability to work independently and as part of a team
- Familiarity with product registration processes
Potential interview questions
Text copied to clipboard!- What experience do you have in pharmaceutical regulatory affairs?
- How do you stay updated on changes in regulations?
- Describe a challenging regulatory submission you managed.
- How do you ensure accuracy in your documentation?
- What regulatory agencies have you interacted with?
- How do you handle tight deadlines for submissions?
- Describe your experience with product registrations.
- How do you collaborate with cross-functional teams?
- What tools or systems have you used for regulatory tracking?
- How do you prepare for regulatory audits?
