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Executive Director, Regulatory Affairs
vor 2 Wochen
Clinipace is a mid-sized, global CRO, with a focus on performing quality work, recognising merit, and developing our employees. Whichever of our departments you join, you are helping to improve the lives of people globally, by contributing to the development of new medications and devices, and thereby helping solve the healthcare challenges that affect us all. If you are looking for the next step in your career and want to work with a company that focuses on performing quality work, recognises merit and develops its employees then we would like to hear from you. At present we are looking for an Executive Director of Regulatory Affairs to join our team.
Why should you join Clinipace? Well, you can expect a great working atmosphere, to join small and collaborative teams, the opportunity to work with innovative, cutting edge pharmaceutical and biotech companies and the chance to work fully home based.
**Job Location**: Zurich, Switzerland - either home or office based
**Job Overview**:
**Job Duties and Responsibilities**:
- Prepare technical content for and review of regulatory documentation and submissions.
- Provide regulatory guidance internally to project teams, functional areas and externally to clients.
- Develop client regulatory plans including timelines, submission documentation, communication, and reporting and tracking of regulatory deliverables.
- Develop regional and/or global strategic plans for the development of client drug product.
- Establish and direct cross-functional teams of internal and external personnel to deliver client projects.
- Oversight of the compilation and review of regulatory documentation and submissions ensuring quality, timeliness and within budget delivery of regulatory tasks.
- Conduct and participate in meetings with regulatory authorities.
- Liaise with regulatory authorities, clients, contractors, consultants and vendors.
- Represent client in regulatory authority meetings, and in meetings with client partners, investors, collaborators, consultants and others.
- Oversee timeliness, quality, communication, and within budget deliverables provided by any contracted regulatory consultants.
- Provide training for internal personnel and supervise staff, as required.
- Co-ordinate the sharing and/or exchange of resources, equipment, and provide support when needed to fulfill timely completion of projects.
- Identify and define contracted regulatory service offerings; work cross-functionally with other areas such as Business Development, Operations, Finance, Quality, and Bids and Proposals.
- Participate in providing RFI/RFP information on regulatory services; participate in bid defense of proposals which include regulatory services.
- May have responsibility for a functional area or geographical region.
**Supervisory Responsibilities**:
- Directly supervises employees if required. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
**Job Requirements**:
**Education**
- Bachelor’s degree in area of concentration commensurate with responsibility.
- Post-graduate degree (MSc or PhD) and leadership role in academia or pharmaceutical industry highly desirable.
**Experience**
- 12+ years’ work experience commensurate with functional area of responsibility; or combination of work experience, education or other related industry experience in similar role.
- Experience working in academic, pharmaceutical, biotechnology or CRO industry preferred
Schedule:
- Monday to Friday
