As a pivotal member of our organization, we are seeking a seasoned Regulatory Affairs Professional to drive compliance and ensure seamless regulatory navigation.
The ideal candidate will possess in-depth knowledge of pharmaceutical legislation, coupled with excellent analytical and problem-solving skills.
Responsibilities
* Develop and implement strategic plans to guarantee adherence to laws and regulations
* Prepare and submit comprehensive registration dossiers for pharmaceutical products
* Stay abreast of regulatory updates and ensure the company remains compliant
* Collaborate with internal teams to facilitate pre-authorization and post-authorization phases
* Participate in audits and inspections providing expert support and necessary information
* Design and update localized regulatory documentation
Requirements
* Academic background in Pharmacy, Chemistry, or a related field
* Proven experience in pharmaceutical regulatory affairs
* Fluency in English is essential
* Strong verbal and written communication skills
* Ability to work independently and as part of a team