15 Aug
|
Naukri Healthcare Jobs
|
India
15 Aug
Naukri Healthcare Jobs
India
Roles and Responsibility
Develop and implement regulatory strategies to achieve business objectives.
Prepare and review regulatory documents such as clinical trial applications and marketing authorizations.
Collaborate with cross-functional teams including legal, quality assurance, and clinical operations.
Conduct thorough reviews of regulatory submissions to ensure compliance with relevant laws and regulations.
Provide guidance on regulatory requirements to internal stakeholders.
Stay up-to-date with changing regulatory settings and develop contingency plans.
Job Requirements
Bachelor's degree in Life Sciences or a related field.
Minimum 2 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
Strong knowledge of FDA regulations, GCP guidelines, and ICH guidelines.
Excellent analytical, problem-solving, and communication skills.
Ability to work effectively in a fast-paced setting and meet deadlines.
Solid attention to detail and ability to manage multiple tasks simultaneously.
📌 Senior Regulatory Affairs Associate Hyderabad (India)
🏢 Naukri Healthcare Jobs
📍 India