Regulatory Affairs Specialist Job Summary
The Regulatory Affairs Specialist will play a pivotal role in ensuring the company's products comply with regulatory requirements across various regions. This individual will be responsible for preparing and submitting high-quality dossiers, reviewing data, and maintaining effective communication with stakeholders.
Requirements:
* A Master's or Bachelor's degree in Science, Technology, or Pharmacy
* At least 4 years of experience in Regulatory Affairs
* Strong understanding of health authority expectations for pharmaceuticals in EU, US, and ROW regions
* Excellent organizational, time management, and attention to detail skills
* Critical thinking and problem-solving abilities
* Strong interpersonal and communication skills
* Experience working with multiple stakeholders
Key Skills/Experience Requirements
This role requires an effective combination of qualifications, skills, and experiences. The ideal candidate will possess organization skills, time management skills, and attention to detail. Strong critical thinking and problem-solving abilities are also essential.
As a Regulatory Affairs Specialist, you will work closely with Business Development, Product Launch, Artwork, Supply Chain, and Quality colleagues to ensure alignment in all initiatives. You will also maintain awareness of regulatory requirements and use this information to optimize departmental procedures and processes.
You will be expected to carry out additional tasks on behalf of the Regulatory Affairs Manager as needed. If you have an effective combination of the required qualifications, skills, and experiences, we encourage you to apply for this challenging and rewarding role.