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Title
Text copied to clipboard!Regulatory Affairs Specialist - Pharma
Description
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We are looking for a dedicated and knowledgeable Regulatory Affairs Specialist to join our pharmaceutical team. In this role, you will be responsible for ensuring that our company complies with all the regulations and laws pertaining to our business. You will work closely with many departments within our company, including research and development, production, and marketing, to ensure compliance. Your duties will include reviewing, preparing, and submitting documents to regulatory agencies, staying up-to-date with changes in regulatory legislation and guidelines, advising on the legal and scientific restraints and requirements, and estimating the risk of proposed products. You will also be responsible for developing strategies and plans for regulatory approval, as well as monitoring and setting timelines for licensing applications.
Responsibilities
Text copied to clipboard!- Ensure compliance with regulations set by the pharmaceutical industry.
- Review, prepare, and submit documents to regulatory agencies.
- Stay up-to-date with changes in regulatory legislation and guidelines.
- Advise on the legal and scientific restraints and requirements.
- Estimate the risk of proposed products.
- Develop strategies and plans for regulatory approval.
- Monitor and set timelines for licensing applications.
- Work closely with other departments within the company.
- Ensure that the company's products comply with the regulations in all countries where they are sold.
- Prepare and manage regulatory submissions and documents.
Requirements
Text copied to clipboard!- Bachelor's degree in a related field.
- Experience in a regulatory role within the pharmaceutical industry.
- Knowledge of pharmaceutical regulations and guidelines.
- Strong communication and negotiation skills.
- Ability to work in a team.
- Strong organizational skills and attention to detail.
- Ability to handle multiple projects simultaneously.
- Proficiency in Microsoft Office Suite.
- Ability to work under pressure and meet deadlines.
- Strong problem-solving skills.
Potential interview questions
Text copied to clipboard!- How do you stay up-to-date with changes in pharmaceutical regulations and guidelines?
- Can you describe a time when you had to handle multiple projects simultaneously?
- How do you handle pressure and meet deadlines?
- Can you describe a time when your attention to detail was critical to the success of a project?
- How do you ensure that all departments within the company comply with regulations?