Experience
1 - 3 yrs
Job Location
Mumbai, India
Vacancy
1
Designation
Regulatory Specialist
Job Type
Not specified
Job Description
We are looking for a highly skilled and experienced Pharmacovigilance and Regulatory Specialist to join our team at a reputed pharmaceutical company in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a strong background in pharmacovigilance and regulatory affairs, with excellent analytical and problem-solving skills.
Roles and Responsibility
- Develop and implement pharmacovigilance strategies to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to identify and mitigate potential risks associated with drug development.
- Conduct thorough reviews of clinical trial data to ensure accuracy and completeness.
- Prepare and submit regulatory documents, including clinical study reports and marketing authorizations.
- Stay up-to-date with changing regulatory requirements and guidelines.
- Provide training and guidance to internal stakeholders on pharmacovigilance and regulatory matters.
Job Requirements
- Strong knowledge of pharmacovigilance principles and practices.
- Experience with regulatory requirements, including FDA regulations and GCP guidelines.
- Excellent analytical and problem-solving skills, with attention to detail.
- Strong communication and collaboration skills, with ability to work effectively with cross-functional teams.
- Ability to prioritize tasks and manage multiple projects simultaneously.
- Strong organizational and time management skills, with the ability to meet deadlines.