Company: i-Pharm Consulting
Closing Date: 24 Jan 17
Salary (£): Negotiable
Regional Regulatory Affairs Manager (m/w) EUOffice-based in Germany or SwitzerlandTasks and Responsibilities:- Responsible for all regional regulatory strategic and operational tasks for a range of products in the assigned franchise/TA. The responsibilities cover products under development and/or products licensed in the European Union.- Develop and execute regional strategies, as well as contribute to global regulatory strategies/plans. ...
Regional Regulatory Affairs Manager (m/w) EU
Office-based in Germany or Switzerland
Tasks and Responsibilities:
- Responsible for all regional regulatory strategic and operational tasks for a range of products in the assigned franchise/TA. The responsibilities cover products under development and/or products licensed in the European Union.
- Develop and execute regional strategies, as well as contribute to global regulatory strategies/plans.
- Closely cooperate with regional and local regulatory managers regarding new license applications for development products and for relevant change applications with a view to obtain HA approval in the fastest and most efficient way while ensuring compliance with the regional regulatory requirements pertaining to product approval and license maintenance.
- Interact with Global Regulatory Lead and other Global Regulatory Affairs Strategy Team members to manage and resolve cross-functional issues.
- Actively support regional efforts to establish and maintain effective working relationships with respective regional Regulatory Agencies and other key external stakeholders and supports regional and local regulatory managers for these activities.
- Deputize for the EU Regulatory Affairs Franchise/TA lead as appropriate.
- A degree in Life science (at least BSc) or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous
- At least 5 years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience.
- Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (relevant) regional Regulatory Authorities.
- Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product as well as the principles of GMP, GCP and GLP.
- Demonstrated ability to lead and influence, as well as deal with rapid change.
- Ability to operate with minimal to no supervision and to establish professional, credible relationships internally and externally.
- Fluent in English.
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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