Regulatory Affairs Expert

3 days ago


Malmo, Skåne, Sweden Sever Pharma Solutions Full time
About Regulatory Affairs

We are a leading pharmaceutical company committed to delivering high-quality products that meet the evolving needs of our customers. Our regulatory affairs team plays a critical role in ensuring that our products comply with regulatory requirements and industry best practices.

The successful candidate will be responsible for ensuring that our quality management system meets regulatory requirements and industry best practices. This includes developing and implementing quality policies, procedures, and standards, as well as conducting regular audits and assessments to identify areas for improvement.

The Quality Assurance Manager will work closely with cross-functional teams to align quality initiatives with business objectives. The ideal candidate will have a strong background in quality assurance, excellent communication and interpersonal skills, and the ability to work effectively in a fast-paced environment.

Key Responsibilities
  1. Develop and implement quality policies, procedures, and standards.
  2. Conduct regular audits and assessments to identify areas for improvement.
  3. Provide leadership and guidance to ensure that quality systems are robust, effective, and efficient.
  4. Collaborate with cross-functional teams to align quality initiatives with business objectives.
  5. Communicate quality-related issues and recommendations to management and stakeholders.
  6. Ensure compliance with regulatory requirements and industry best practices.
Requirements

To be successful in this role, you will need:

  • A degree in a relevant field (e.g., pharmacy, natural sciences, or engineering).
  • Proven experience in quality assurance, preferably in a pharmaceutical industry setting.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a fast-paced environment.
  • Strong analytical and problem-solving skills.
  • Knowledge of regulatory requirements and industry best practices.


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