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Job Details

Regulatory Affairs Manager (m/w)

Company: i-Pharm Consulting
Location: Basel
Reference: CRN223
Closing Date: 09 Dec 16
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

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. ...

Requirements:

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


Requirements:

- 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


To Apply:

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.

www.i-pharmconsulting.com

If you would like to discuss this vacancy further, please call Recruitment Consultant Christian Rommerskirchen on +49 89 71 677 25 41 or email: crommerskirchen@i-pharmconsulting.com.

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.

Apply for this job: Regulatory Affairs Manager (m/w)

Contact Information:

Address:  Head Office
212 New King’s Road London
SW6 4NZ
England
Reasons to work for i-Pharm Consulting
Tel:  +44 (0) 20 3189 2299
Website:  Visit Our Web Site

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