Regulatory Affairs Expert for Clinical Trials with Senior Leadership
hace 2 semanas
Job Summary
We are seeking a seasoned Regulatory Affairs Specialist to lead the preparation, submission, and maintenance of regulatory documents for clinical trials. The ideal candidate will have extensive experience in the pharmaceutical or biotech industry and possess strong knowledge of global regulatory requirements and guidelines.
About the Role
- Develop and implement strategies to ensure compliance with regulatory standards and mitigate risks associated with clinical trials.
- Collaborate with internal teams to provide expertise and guidance on regulatory requirements and standards.
- Interface with regulatory agencies to address inquiries, submissions, and approvals.
- Monitor changes in regulations and guidelines to stay up-to-date and ensure compliance.
Your Profile
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Strong knowledge of global regulatory requirements and guidelines for clinical trials.
- Proven ability to manage regulatory submissions and interactions with regulatory agencies.
- Excellent communication, attention to detail, and problem-solving skills.
What We Offer
- A competitive salary of approximately $120,000 per year.
- An attractive benefits package including various annual leave entitlements, health insurance options, and retirement planning offerings.
- The opportunity to work with a world-leading healthcare intelligence and clinical research organization like ICON Plc.
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