Senior Regulatory Affairs Specialist with Experience in Clinical Trials
hace 5 días
Senior Regulatory Affairs Specialist with Experience in Clinical Trials
At ICON Plc, we're seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. This role will be responsible for leading the preparation, submission, and maintenance of regulatory documents for clinical trials.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with global regulations and guidelines.
- Provide expert guidance on regulatory requirements and standards to internal teams.
- Collaborate with cross-functional teams to support regulatory aspects of clinical trial planning and execution.
- Manage activities associated with obtaining initial, amendment, and other central authority approvals.
- Ensure that IP labels are in adherence to country requirements and submitted where applicable.
- Provide consultancy to clients on country-specific regulatory issues.
- Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs, and BDMs.
- Adapt Informed Consent Forms according to local regulations.
- Provide mentoring and training to entry-level positions as needed.
Requirements:
- 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. Experience in Clinical Trials.
- 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.
- Advanced English for Reading / Writing / Speaking.
- Desirable: e-systems knowledge on CTMS, PhlexEview, PSO, BOX.
What ICON Plc Offers:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and inclusive work environment.
- Recognition and rewards for high performance.
- Global Employee Assistance Programme, LifeWorks.
- Life assurance.
- Flexible country-specific optional benefits.
ICON Plc is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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