Company: i-Pharm Consulting
Closing Date: 09 Dec 16
Salary (£): Negotiable
Regulatory Affairs Manager (m/w)Office-based in BaselMy client is an international top-10 pharmaceutical and biotech company. For their EU headquarters in Basel, I am looking for an experienced Regulatory Affairs Manager to manage all regulatory activities (full lifecycle) for a specific therapeutic area. ...
Regulatory Affairs Manager (m/w)
Office-based in Basel
My client is an international top-10 pharmaceutical and biotech company. For their EU headquarters in Basel, I am looking for an experienced Regulatory Affairs Manager to manage all regulatory activities (full lifecycle) for a specific therapeutic area.
Tasks and Responsibilities:
- Manage both centralized and decentralized filings of branded medicinal products in Europe
- Manage interactions with European Regulatory Authorities
- Coordinate all regulatory aspects of clinical trial applications in Europe
- Participate in the development of RA strategies for new product submissions
- Co-ordinate scientific advice procedures with national competent authorities and/or the EMA
- Provide all post-marketing support for existing products in the specific therapeutic area, including co-ordination and preparation of variations or extension applications to optimize commercial life of products
- Collaborate with project teams, medical and marketing departments and provide appropriate regulatory strategies
- Provide supervision to administrative and regulatory support staff
- Master’s Degree in science or healthcare discipline, ideally with a PhD
- At least 5 years' of EU regulatory affairs experience, preferably gained in a globally acting company
- Experience in managing new submissions and maintenance work
- Minimum of 3 years' experience with processes and requirements in the area of research, development and marketing of innovative pharmaceutical products.
- Good understanding of, and ability to interpret regulatory requirements for medicines in Europe, including awareness of the commercial implications
- In depth knowledge of ICH/GCP standards and regulatory requirements
- Analytical skills to interpret regulatory data and make critical decisions
- Leadership skills for leading teams across different functions and experience in project management
- Experience to work in a global environment and in virtual teams
- Excellent communication and presentation skills
This team-oriented organization is collaborative and diverse; the work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. My client enjoys a sterling reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations
i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in Europe and Germany. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMO’s). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, drug safety and Bioinformatics.
If you would like to discuss this vacancy further, please call Recruitment Consultant Christian Rommerskirchen on +49 89 71 677 25 41 or email: firstname.lastname@example.org.
If this role is not suitable, Christian is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
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