Job Overview:
Two seasoned professionals are required to spearhead our global regulatory strategy and ensure timely, compliant submissions across a diverse product portfolio.
* Drive or support strategic initiatives for new marketing authorizations and post-approval changes
* Collaborate closely with local regulatory teams and health authorities
* Develop and review regulatory dossiers and submission components
* Maintain accurate and up-to-date regulatory databases and project records
* Establish strong relationships with internal stakeholders and external partners
About You:
* Bachelor's degree in Life Sciences or Pharmacy (Master's or Doctoral degree preferred)
* Significant experience in Regulatory Affairs
* Excellent communication, organizational, and prioritization skills
* Ability to work efficiently in high-volume environments
* Experience mentoring or supporting junior colleagues
Key Requirements:
* Proven Regulatory affairs expertise
* Quality compliance for Marketing Authorizations and CMC