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<h1>Regulatory Affairs Manager (m/f)</h1>
<h2>via OPTARES GmbH & Co. KG, Western Germany</h2>
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Our mandator is one of the most important Italian pharmaceutical companies, with excellent role in the
international field in the area of rare diseases.
We are searching as soon as possible for a dedicated and highly motivated
Regulatory Affairs Manager (m/f)
Standort: western Germany
Kennziffer: 10998
Your responsibilities
Develop regulatory strategies for the product portfolio
Close collaboration with the Headquarter and other affiliates referring regulatory strategies and action plans
Lead contact person for Health Authorities referring the drugs of the affiliated company
Prepare and coordinate regulatory submissions for the affiliated company
Ensure regulatory compliance over product life-cycle of the drugs
Work on regulatory inquiries and provide high quality service to the regulatory bodies
Negotiate and communicate effectively with Regulatory Authorities to defend company business interest
Participate in product/project teams with regard to implementation of regulatory requirements
Preparing, implementing, communicating, and coordinating regulatory projects, plans and schedules with
scientific (clinical and preclinical), manufacturing, and business development project team members for
products proposed for indications
Responsible for preparing, implementing, communicating, and coordinating regulatory projects, plans and
schedules with project team members and partners for submission of Investigational New Drug Applications
and Biologic License Applications
Provide the product/project teams with regulatory input during life-cycle of drugs
Generate SOPs for the responsible field
Review and approve medical educational and promotional materials referring regulatory requirements
Develop and maintain regulatory knowledge of German and European regulations
Monitor trends and upcoming changes in the regulatory environment
Take part in regulatory conferences and working groups
Other duties as assigned
Your qualification
Degree in Pharmacy, Biology, Chemistry or comparable; 5-6 years of work experience
A minimum of 5-6 years experience in the international regulatory field (German and European MA)
Preferably also at least 8 years experience in the pharmaceutical Industry
Keen ability to communicate complex scientific data in a straightforward manner
Develop and maintain regulatory knowledge of German and European regulations
Knowledge of BfArM/EMA regulations required - FDA is desirable
Direct liaison experience with refer regulatory bodies required
Knowledge of international regulatory guidelines, GCP and GMP requirements is desirable
Proven record of project and time management experience
Excellent verbal and written communication skills
Good command of German and English
Goals-driven, milestones- and results-oriented
Authentic and reliable team player
Responsible, individual leadership
Well developed representative skills: Friendly, positive, co-operative and competent personality
This position involves travel up to 30 percent of the time
Benefit now from our professional experience to place qualified and motivated professionals into challenging
positions within the broad field of the Life-Science Industry by filling in your profile online at
www.optares-medical.de or by sending your application by e-mail. Please state your favoured region and
expected salary.
We will handle your application absolutely confidential and are delighted to become acquainted with you. Feel
free to get in touch with our consultant Mr. Grumbd; phone 0441 21879-34.
OPTARES GmbH & Co. KG
Tilman Grumbd
Heiligengeist Höfe 8
26121 Oldenburg
Tel: 0441 21879-34
Fax: 0441 21879-16
E-Mail: tilman.grumbd@optares.de
Internet: www.optares-medical.de
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