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Title
Text copied to clipboard!Regulatory Affairs Consultant
Description
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We are looking for a Regulatory Affairs Consultant to join our team and provide expert guidance on regulatory compliance, submissions, and strategy across a range of industries. The ideal candidate will have a deep understanding of regulatory frameworks, including FDA, EMA, and other global authorities, and will be able to interpret and apply these regulations to ensure our clients’ products and processes meet all necessary requirements. As a Regulatory Affairs Consultant, you will be responsible for preparing and reviewing regulatory submissions, advising on product development strategies, and ensuring ongoing compliance with changing regulations. You will work closely with cross-functional teams, including R&D, quality assurance, legal, and marketing, to support product lifecycle management from development through post-market surveillance. Your role will also involve monitoring regulatory trends, assessing their impact on client operations, and developing proactive strategies to address potential challenges. Strong communication skills, attention to detail, and the ability to manage multiple projects simultaneously are essential for success in this role. You should be comfortable working in a fast-paced environment and possess the analytical skills necessary to interpret complex regulatory documents. Experience with electronic submission systems, regulatory intelligence tools, and project management software is highly desirable. If you are passionate about regulatory affairs and enjoy helping organizations navigate the complexities of compliance, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Advise clients on regulatory requirements and compliance strategies.
- Prepare, review, and submit regulatory documents to authorities.
- Monitor and interpret changes in relevant regulations and guidelines.
- Develop regulatory strategies for product development and market entry.
- Liaise with regulatory agencies and respond to queries.
- Support cross-functional teams on regulatory matters.
- Conduct regulatory risk assessments and gap analyses.
- Maintain up-to-date knowledge of global regulatory trends.
- Train internal teams on regulatory best practices.
- Ensure timely completion of regulatory submissions and renewals.
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences, pharmacy, law, or related field.
- Minimum 3 years of experience in regulatory affairs.
- Strong knowledge of FDA, EMA, and other global regulatory frameworks.
- Excellent written and verbal communication skills.
- Ability to manage multiple projects and deadlines.
- Attention to detail and strong analytical skills.
- Experience with electronic submission systems (e.g., eCTD).
- Proficiency in regulatory intelligence and project management tools.
- Ability to work independently and as part of a team.
- Strong problem-solving and decision-making abilities.
Potential interview questions
Text copied to clipboard!- What experience do you have with regulatory submissions?
- How do you stay updated on changing regulations?
- Describe a challenging regulatory issue you resolved.
- Which regulatory authorities have you interacted with?
- How do you prioritize multiple regulatory projects?
- What tools do you use for regulatory intelligence?
- Have you worked with cross-functional teams before?
- Describe your experience with electronic submission systems.
- How do you handle tight deadlines in regulatory projects?
- What industries have you provided regulatory consulting for?
