Senior Regulatory Affairs Professional
1 week ago
Lifelancer is seeking an experienced Senior Regulatory Affairs professional to join our team. As a key member of our organization, you will play a critical role in ensuring compliance with regulatory requirements and advancing new medications from discovery to reality.
Job DescriptionWe are looking for a seasoned professional with a strong background in regulatory affairs, who can lead our team in navigating the complex regulatory landscape. Your expertise will be instrumental in reviewing study budgets, participating in business development activities, and preparing regulatory sections of proposals and feasibility reports.
In this role, you will also coordinate and manage regulatory ethics committee submissions, maintain approvals throughout EMEA, Asia Pacific, and Latin America regions, and ensure accurate compilation, management, and tracking of submissions.
You will provide expert regulatory advice, contribute to regulatory project work, and effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical Scientific Affairs staff.
Your responsibilities will include providing training, coaching, and mentoring to junior members of staff, as well as line managing junior members of staff when required.
Required Skills and Qualifications- 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 experience within clinical research (e.g., CRA, Reg Affairs);
- Minimum 5 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience;
- Proficient in cross-cultural communication and proficient in both spoken and written English.
The estimated salary range for this position is $120,000 - $150,000 per annum, depending on experience and qualifications.
BenefitsLifelancer offers a comprehensive benefits package, including medical insurance, retirement plan, paid time off, and opportunities for professional growth and development.
About LifelancerLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented professionals with exciting opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.
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