For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Vice President of European Regulatory Operations (EU VP RO) is responsible for the success of the Regulatory Operations team in Europe, to ensure excellence. Success is defined as growth, profitability and employee stability. The EU VP RO is responsible for the Regulatory Operations team at ProPharma Group. The EU VP RO has responsibilities and inputs into the following core areas:
- Client experience
- Group Structure & Planning
- Recruitment
- Workload Allocation & Project Resourcing
- Line Management
- Regulatory Affairs Activities (strategic & operational)
- Business Development & Marketing
- Finance & Invoicing
- Quality & Team performance metrics
- Training
- Processes in Regulatory Operations
Necessary Skills and Abilities:
- Has experience of leading Departments, Regulatory teams and Senior Regulatory Managers
- Strong commercial awareness and aptitude
- Strong knowledge of and insight in the developments within own disciplines.
- Strong knowledge of relevant national and international standards and guidelines in the pharmaceutical law and relevant guidelines.
- Strong knowledge of the products and services of the organization as well as the product and service portfolios of competitors and relevant markets.
- Strong project management skills.
- Knowledge and understanding of all social, political, financial, economic and technical affairs that are strategically relevant to the organisation.
- Strong interpersonal skills, communication and negotiation skills.
- Excellent attention to detail and focus on quality.
- Strong verbal and written communication skills in.
- Ability to prioritize workload and meet deadlines both for self and for team.
- Ability to work independently and make decisions.
- Capable of resolving conflict in a constructive manner.
- Ability to collaborate with others to meet company objectives.
- Ability to speak effectively in interpersonal situations and presentations before groups of employees and clients.
- Flexible and proactive toward changing needs.
- Proficiency in MS Office and Finance systems.
- Must be willing to travel, when required.
Education and Experience:
- Educated to BSc level minimum, in a relevant scientific field.
- 15 years plus regulatory and management experience (consultancy preferred).
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
- ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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