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Senior Regulatory Affairs Manager
Eingestellt von Berry Technical
Gesuchte Skills: Client, Marketing
Projektbeschreibung
Senior Regulatory Affairs Manager - CMC
CHF: Negotiable
3-6 month contract
Bern, Switzerland
Our client, an extensive global giant in their industry, is seeking to appoint a Senior Regulatory Affairs Manager to join them on client site in Bern. As the Senior Regulatory Affairs Manager you will be responsible for assisting our client with drawing on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any critical regulatory documentation of specified regulatory submissions.
Responsibilities:
*Responsible for designated products projects working within overall policies and strategies
*Prepares regulatory documentation for submissions such as clinical trial applications, marketing authorization applications, variations, renewals etc. in a timely and efficient manner.
*Responsible for dossiers establishment, timeplan coordination and regulatory submission plan and coordination of the activities between relevant function (development group, project team, clinical, etc.)
*Revise the CMC documentation and ensure good quality of the regulatory relevant documentation
*Prepares the concept for the final regulatory strategy with respect to WHO and is responsible for the harmonization of WHO and NRA strategies (issues, submissions, meeting etc.)
*Responsible for the good quality and conformity to regulatory requirements of the submissions
*Prepares position papers and the regulatory sections of project plans for review and approval by supervisor
*Consulted on regulatory strategy, plans and manufacturing change control proposals
*Authorizes and drafts original texts (eg summaries, linking texts, labels and leaflets, letters). Reviews and comments on documents from other departments.
*Represents RA in project teams
*Being an interface between R&D, marketing, quality, production, company subsidiaries and partner companies
Must be fluent English speaker and have the ability to work in Switzerland, unfortunately our client is unable to offer sponsorship. If you think this may be an opportunity for you please email Alexandra and we can discuss your application further.
CHF: Negotiable
3-6 month contract
Bern, Switzerland
Our client, an extensive global giant in their industry, is seeking to appoint a Senior Regulatory Affairs Manager to join them on client site in Bern. As the Senior Regulatory Affairs Manager you will be responsible for assisting our client with drawing on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any critical regulatory documentation of specified regulatory submissions.
Responsibilities:
*Responsible for designated products projects working within overall policies and strategies
*Prepares regulatory documentation for submissions such as clinical trial applications, marketing authorization applications, variations, renewals etc. in a timely and efficient manner.
*Responsible for dossiers establishment, timeplan coordination and regulatory submission plan and coordination of the activities between relevant function (development group, project team, clinical, etc.)
*Revise the CMC documentation and ensure good quality of the regulatory relevant documentation
*Prepares the concept for the final regulatory strategy with respect to WHO and is responsible for the harmonization of WHO and NRA strategies (issues, submissions, meeting etc.)
*Responsible for the good quality and conformity to regulatory requirements of the submissions
*Prepares position papers and the regulatory sections of project plans for review and approval by supervisor
*Consulted on regulatory strategy, plans and manufacturing change control proposals
*Authorizes and drafts original texts (eg summaries, linking texts, labels and leaflets, letters). Reviews and comments on documents from other departments.
*Represents RA in project teams
*Being an interface between R&D, marketing, quality, production, company subsidiaries and partner companies
Must be fluent English speaker and have the ability to work in Switzerland, unfortunately our client is unable to offer sponsorship. If you think this may be an opportunity for you please email Alexandra and we can discuss your application further.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Marketing/Vertrieb