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Senior Manager, Regulatory Affairs Specialist

hace 2 meses

Madrid, Madrid, España Worldwide Clinical Trials A tiempo completo
About Us

Worldwide Clinical Trials is a leading global contract research organization (CRO) that partners with biotechnology and pharmaceutical companies to create customized solutions that advance new medications from discovery to reality.

Our company's scientific heritage is anchored in our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. We develop flexible plans and solve problems quickly for our customers.

We have a talented team of 3,000+ professionals spanning 60+ countries. We are united in our cause with our customers to improve the lives of patients through new and innovative therapies.

Our Values

We believe everyone plays an important role in making a world of difference for patients and their caregivers. Our hands-on, accessible leaders, cohesive and supportive teams, and commitment to diversity and inclusion enable professionals from all backgrounds and experiences to succeed.

We prioritize cultivating a diverse and inclusive environment that promotes collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

About the Role

We are seeking a Senior Manager, Regulatory Affairs to join our team. The successful candidate will be responsible for:

  1. Reviewing study budgets and costing pertaining to contract negotiation, participating in business development activities, preparing regulatory sections of proposals and feasibility reports, and attending bid defense meetings to meet business needs.
  2. Coordinating and managing regulatory and ethics committee submissions and maintaining approvals throughout EMEA, Asia Pacific, and Latin America regions, ensuring accurate compilation, management, and tracking of submissions.
  3. Providing expert regulatory advice and contributing to regulatory project work. Effectively communicating the status of submissions with the Sponsor, Project Manager, CRAs, Medical & Scientific Affairs staff. Contributing towards the preparation of technical documentation such as IMPDs and IBs, reviewing, and making recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements.
  4. Providing training, coaching, and mentoring to junior members of staff, and may be required to line manage junior members of staff.
Requirements

The ideal candidate will have:

  1. Clearly proven leadership and organizational management skills.
  2. Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
  3. Excellent written and verbal communication skills to clearly and concisely present information.
  4. Relationship-building competency combined with demonstrated comfort supporting Business Development at face-to-face meetings.
  5. Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment.
  6. Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.
Education and Experience

The successful candidate will have:

  1. A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science, OR...
  2. 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).
  3. Minimum 7 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience.
  4. Proficient in cross-cultural communication and proficient in both spoken and written English.