
Advanced Regulatory Affairs Position
1 day ago
We are seeking an experienced Senior Regulatory Affairs Specialist to join our team. This role will play a pivotal part in ensuring the success of diverse clinical trials by navigating the complex regulatory landscape.
- Negotiate with stakeholders and manage submissions to regulatory authorities across EMEA, Asia Pacific, and Latin America.
- Develop and implement strategies for global regulatory standards and ensure compliance with evolving regulations.
As a Senior Regulatory Affairs Specialist, you will be responsible for:
- Reviewing and preparing regulatory sections of proposals and feasibility reports.
- Attending bid defense meetings and participating in business development activities.
- Providing expert regulatory advice and contributing to regulatory project work.
- Effectively communicating status of submissions with sponsors, project managers, CRAs, and medical & scientific affairs staff.
Requirements:
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years of experience within clinical research.
- Minimum 5 years within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experience across the APAC region.
- Proficient in cross-cultural communication and proficient in both spoken and written English.
What We Offer:
- A dynamic and supportive work environment that encourages collaboration and creativity.
- Equal opportunities for professional growth and development.
- A competitive compensation package and benefits.
Join our team and contribute to making a world of difference in the lives of patients and their caregivers.
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