Senior Regulatory Affairs Manager

hace 7 meses

Ourense provincia, España Worldwide Clinical Trials A tiempo completo

**Requisition Number**
**7297**

**Employment Type***:
**Regular**

**Who we are**

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

In this role, The Senior Manager, Regulatory Affairs provides project representation and input to projects awarded for all stages of the drug development cycle and ensures the smooth running of the Regulatory Affairs Department.

**What you will do**
- Review study budgets and costing pertaining to contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
- Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
- Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country specific requirements
- Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff

**What you will bring to the role**
- Clearly, proven leadership and organizational management skills are essential attributes
- Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
- Excellent written and verbal communication skills to clearly and concisely present information
- Relationship-building competency combined with demonstrated comfort supporting Business Development at face-to-face meeting
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment

**Your experience**
- 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 7 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

**Why Worldwide**
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

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