Regulatory Affairs Leader
3 days ago
Join Lifelancer, a pioneering talent-hiring platform in Life Sciences and IT. We are seeking an experienced Senior Manager/Associate Director to spearhead regulatory affairs for our clients.
Salary: $120,000 - $180,000 per year, depending on qualifications and experience.
About the RoleThis is a challenging opportunity to lead global regulatory strategies for product development and approval, ensuring alignment with corporate objectives and regulatory requirements.
The ideal candidate will have a minimum of 6 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, preferably in rare disease drug development. Strong leadership and communication skills, along with excellent interpersonal skills, are essential.
Key Responsibilities:
- Develop and implement global regulatory strategies for assigned programs from early stages through commercialization.
- Represent Regulatory on cross-functional product and study teams, providing strategic regulatory guidance and support.
- Oversee the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, and Annual Reports.
- Collaborate with internal and external stakeholders, manage third-party vendors and consultants, and ensure high-quality submissions.
Requirements:
- Bachelor's degree in health sciences or related field; an advanced degree is preferred.
- Experience working with US and EU Agencies, with Japanese Regulatory Agencies being a plus.
- Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines.
- Excellent leadership and communication skills, with a proven ability to foster effective interactions with regulatory agencies.
Benefits:
- A competitive salary and benefits package.
- The opportunity to work with a talented team of professionals in a dynamic and innovative environment.
- Professional growth and development opportunities.
About Lifelancer
Lifelancer is a leading talent-hiring platform in Life Sciences and IT, connecting talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. Our mission is to deliver meaningful medicines for people who need them, while fostering a culture of innovation, collaboration, and diversity.
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