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Senior Regulatory Affairs Manager
Eingestellt von Edelway
Gesuchte Skills: Marketing, Natural
Projektbeschreibung
Senior Regulatory Affairs Manager
Edelway is a Services Consultancy based in Switzerland. One of our best clients, a global pharmaceutical company, based in the Bern area, is currently looking for a Senior Regulator Affairs Manager to join them on a long term basis.
Language: English, German is a plus.
Start Date: ASAP
Rate: Excellent
THE ROLE
*Drawing on relevant expertise and information from both internal and external sources
*Make major contributions towards the preparation of any critical regulatory documentation of specified regulatory submissions.
*Responsible for designated product projects, working within overall policies and strategies.
*Able to prepare regulatory documentation for submissions such as clinical trial applications, marketing authorization applications, variations, renewals etc.
*Responsible for dossier establishments, timeplan coordination, regulatory submission plans and coordination of the activities between relevant functions (development group, project team, clinical, etc.)
*Revise and ensure good quality of the regulatory relevant documentation
*Prepare the final regulatory strategy with respect to the WHO
*Harmonize the WHO and NRA strategies (issues, submissions, meeting etc.)
*Prepare position papers and the regulatory sections of project plans for review and approval by supervisors.
*Consult on regulatory strategy plans and manufacturing change control proposals
*Authorizes and draft original texts (eg summaries, linking texts, labels and leaflets, letters).
*Represent the RA in project teams and be an interface between R&D, marketing, quality, production, company subsidiaries and partner companies
YOU'LL NEED
*A scientific degree in natural science or equivalent with at least two years of working experience in the RA field, preferably, with a focus on vaccines, biologics or pharmaceuticals
*Flexibility in working hours is required
*Excellent customer service, interpersonal, communication and team collaboration skills
*Able to follow change management for internal guidelines.
If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.
Edelway is a Services Consultancy based in Switzerland. One of our best clients, a global pharmaceutical company, based in the Bern area, is currently looking for a Senior Regulator Affairs Manager to join them on a long term basis.
Language: English, German is a plus.
Start Date: ASAP
Rate: Excellent
THE ROLE
*Drawing on relevant expertise and information from both internal and external sources
*Make major contributions towards the preparation of any critical regulatory documentation of specified regulatory submissions.
*Responsible for designated product projects, working within overall policies and strategies.
*Able to prepare regulatory documentation for submissions such as clinical trial applications, marketing authorization applications, variations, renewals etc.
*Responsible for dossier establishments, timeplan coordination, regulatory submission plans and coordination of the activities between relevant functions (development group, project team, clinical, etc.)
*Revise and ensure good quality of the regulatory relevant documentation
*Prepare the final regulatory strategy with respect to the WHO
*Harmonize the WHO and NRA strategies (issues, submissions, meeting etc.)
*Prepare position papers and the regulatory sections of project plans for review and approval by supervisors.
*Consult on regulatory strategy plans and manufacturing change control proposals
*Authorizes and draft original texts (eg summaries, linking texts, labels and leaflets, letters).
*Represent the RA in project teams and be an interface between R&D, marketing, quality, production, company subsidiaries and partner companies
YOU'LL NEED
*A scientific degree in natural science or equivalent with at least two years of working experience in the RA field, preferably, with a focus on vaccines, biologics or pharmaceuticals
*Flexibility in working hours is required
*Excellent customer service, interpersonal, communication and team collaboration skills
*Able to follow change management for internal guidelines.
If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Marketing/Vertrieb