Director Regulatory Affairs, Europe
The Vaxxinova Group, headquartered in Nijmegen, the Netherlands, was officially named and founded in 2010 but can rely on expertise and presence originating from the 1960s. Their current network comprises production, research & development, sales and diagnostic facilities in 10 countries: Brazil, Chile, Germany, Italy, Japan, Jordan, Norway, the Netherlands, Thailand and the USA. Vaxxinova is active in more than 60 countries.
The Director RA Europe, leads the Regulatory Affairs and Pharmacovigilance activities in Nijmegen, Netherlands, and Münster, Germany, with the aim to register new products in Europe. He/she rovides short to medium-term tactical direction and operational oversight and may specify new products, processes and standards to support corporate strategies including interpretation and application. He/she is responsible for the tactical direction for registration submissions, variations, renewals progress reports, and periodic experience reports and is actively involved in registration procedures for livestock vaccines in Europe.
- Interacts with European regulatory agency to expedite approval of pending regulatory procedures.
- Serves as regulatory liaison throughout product lifecycle.
- Participates in product plan development and implementation, regulatory strategy, and risk management meetings.
- Ensures timely submissions of files for registration of new vaccines and renewals of marketed products.
- Serves as regulatory representative to marketing, research teams and regulatory agencies.
- Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
- Serves as the regulatory representative for pharmacovigilance issues of European products.
- Ensure the organization’s regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.
- Establish and maintain positive relationships with government agencies and other regulatory authorities; represent the organization in matters before regulatory, legislative, or industry standards agencies so the organization’s interests are advanced.
- Testify, lobby, negotiate, and assist in preparation and presentation of issues before regulatory and legislative commissions.
- Ensure audits have met organization and government standards. Consult on an ongoing basis on related issues with the executive leadership team.
- Broad experience in regulatory affairs, particularly in European registration procedures.
- PhD in life sciences and/or DVM, preferably followed by several years of post-doc experience.
- Track record in veterinary regulatory affairs, particularly in successful registration of biological products.
- Experienced in discussions and diplomatic negotiation skills with regulatory authorities.
- Experience with regulatory project management in commercial vaccine development setting.
- Ability to supervise and coach a team of regulatory colleagues in line with company and personal goals.
- Proven team worker.
- Critical and good communication skills.
- Proven ability to work with people from different cultural backgrounds.
- Excellent English proficiency (written and spoken) is necessary.
- Ability to interact with and convince different stakeholders.
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