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Title
Text copied to clipboard!Specialist in Regulatory Affairs within Pharma
Description
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We are looking for a Specialist in Regulatory Affairs within Pharma who will be responsible for ensuring that all pharmaceutical products comply with applicable laws and regulations. The role involves working closely with both internal teams and external authorities to manage approvals, reporting, and documentation related to pharmaceutical regulation. You will be a key person in interpreting and implementing regulatory requirements, as well as supporting development and marketing teams with regulatory advice. It is important that you have deep knowledge of national and international regulations, such as EMA and FDA, and experience working with drug applications, variations, and safety reporting. The role requires analytical skills, accuracy, and the ability to communicate complex information clearly. You will also participate in training and updates to ensure the company is always up to date with the latest regulatory changes. We value a proactive attitude and the ability to work independently in a dynamic environment. As a specialist in this area, you contribute to ensuring patient safety and company compliance, which is crucial for business success and market trust.
Responsibilities
Text copied to clipboard!- Manage regulatory applications and approvals
- Ensure compliance with national and international regulations
- Communicate with authorities such as the Medical Products Agency, EMA, and FDA
- Support internal teams with regulatory advice
- Update and maintain regulatory documentation
- Participate in training and stay updated on regulatory changes
- Analyze and interpret new regulatory requirements
- Report safety-related issues and variations
- Collaborate with development and marketing teams
- Contribute to improving internal processes for regulatory matters
Requirements
Text copied to clipboard!- Relevant university degree in life sciences or similar
- Experience in regulatory work within the pharmaceutical industry
- Good knowledge of EMA, FDA, and national regulations
- Strong communication and analytical skills
- Ability to work independently and in teams
- Meticulous and structured work methodology
- Fluent in Swedish and English, both spoken and written
- Experience with drug applications and variations
- Knowledge of safety reporting and pharmacovigilance
- Proactive and solution-oriented attitude
Potential interview questions
Text copied to clipboard!- What experience do you have with regulatory processes within pharma?
- How do you stay updated on changes in regulations?
- Can you give an example of a challenge you solved in regulatory matters?
- How do you handle communication with authorities?
- Which systems or tools have you used for regulatory documentation?
- How do you ensure quality and accuracy in your work?
- Do you have experience with international regulatory applications?
- How do you collaborate with other departments on regulatory issues?
- Can you describe a situation where you had to interpret complex regulations?
- What motivates you in the role as a specialist in regulatory affairs?
