We are looking for a highly skilled and experienced Regulatory Submission Specialist to join our team at a reputed pharmaceutical company in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a solid background in regulatory affairs and submission preparation.
Roles and Responsibility
- Prepare and review regulatory submissions, including clinical trial applications, marketing authorizations, and periodic safety update reports.
- Ensure compliance with relevant regulations, guidelines, and standards.
- Collaborate with cross-functional teams, including R&D;, quality assurance, and legal affairs.
- Develop and maintain relationships with regulatory authorities and stakeholders.
- Stay updated with changing regulatory requirements and implement necessary changes.
- Provide training and guidance to junior staff on regulatory affairs and submission preparation.
Job Requirements
- Bachelor's degree in Pharmacy or related field; advanced degree preferred.
- Minimum 5 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
- Strong knowledge of regulatory requirements, guidelines, and standards.
- Excellent communication, writing, and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficient in regulatory software and systems.