Regulatory Affairs Director

2 weeks ago

London, Greater London, United Kingdom Lifelancer Full time

Lifelancer: Where Passion Meets Opportunity

We believe that everyone plays a vital role in making a significant impact on patients' lives and their caregivers. Our company is committed to creating an environment where professionals from diverse backgrounds can succeed, collaborate, and thrive.

About the Role:

  • This Senior Regulatory Affairs Manager will be responsible for reviewing study budgets and costs related to contract negotiation, participating in business development activities, preparing regulatory sections of proposals and feasibility reports, and attending bid defense meetings to meet business objectives.
  • The ideal candidate will also coordinate and manage regulatory ethics committee submissions across EMEA, Asia Pacific, and Latin America regions, ensuring accurate compilation, management, and tracking of submissions.
  • They will provide expert regulatory advice, contribute to regulatory project work, and effectively communicate submission status with the Sponsor, Project Manager, CRAs, Medical Scientific Affairs staff.
  • In addition, this individual may be required to provide training, coaching, and mentoring to junior members of staff and potentially line-manage junior team members.

About You:

  • We are seeking a highly skilled and experienced leader with a proven track record of leadership and organizational management skills, as well as strong planning, strategizing, managing, monitoring, scheduling, and critiquing abilities.
  • The successful candidate will have excellent written and verbal communication skills to present information clearly and concisely, as well as relationship-building competencies combined with comfort supporting Business Development at face-to-face meetings.
  • A strong interpersonal skillset in a fast-paced, deadline-oriented, and changing environment is essential, along with the ability to handle multiple tasks efficiently.

Your Qualifications:

  • A minimum four-year college degree in a medical, biological, physical, health, pharmacy, or related science field, or equivalent education/training (nursing degree or life science degree) with eight years of experience in clinical research, or five years in pharmaceutical/CRO industry with senior-level regulatory or clinical start-up experience.
  • Proficiency in cross-cultural communication and proficiency in both spoken and written English are required.

About Lifelancer:

Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT domains. If you are passionate about your career and want to make a meaningful difference, join our community today

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