7 days ago

Senior DRA Project Manager

Kelly Scientific Resources KSRN

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Senior DRA Project Manager

Our customer, an international, pharmaceutical company with HQ in Allschwil (Switzerland), is looking for a communicative and collaborative

Senior DRA Project Manager

Are you looking for an enthusiastic work environment that fosters an open communication and is looking for your innovation and creativity? Are you experienced in working in a global role and enjoy it? This is your chance to make an impact.

Your responsibilities:
* Provide regulatory strategy for various countries (e.g. US, EU, Canada, Japan, Australia, New Zealand and Switzerland)
* Liaise and coordinate all documentation, submissions and activities with affiliates/partners for NCE dossiers and life cycle of marketed products
* Coordinate the archiving of submitted registration dossiers and other relevant Health Authority communications
* Keep up to date with international regulatory guidelines (new registrations, variations and renewals of marketed products)
* Respond to Health Authority questions
* Apply for the preparation and shipment of registration samples
* Evaluate and review the regulatory activities of potential and existing business partner contracts and quotations
* Deputize the Group Leader, as necessary (e.g. participating at meetings)
* Future opportunity to mentor the Junior International DRA Project

Your background:
* Degree in life science and several years of previous work experience in regulatory affairs, preferably with regions outside of the EU and US
* Good knowledge of international regulatory legislations and guidelines
* Ability to work in a multicultural environment
* Excellent communication, interpersonal, negotiation and problem solving skills
* Capable of working independently as well as effective team player
* Accuracy and good project management skills
* Excellent command of spoken and written English, other languages are advantageous

Start: asap
Contract: permanent position
Workload: 100%

Do you bring the required experience and are you interested in this excellent opportunity? If yes, we look forward to receiving your application documents (CV, diploma, reference letters). Simply send them to Ms Nicole Blum (nicole.blum(at)kellyservices.ch) or apply online.
We look forward to meeting you!