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Global Program Regulatory Manager (Scientific)
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Client, Support
Projektbeschreibung
Only English-written CV will be accepted.
Please note that only selected candidates will be contacted.
For our Client in BASEL, we are looking for a GLOBAL PROGRAM REGULATORY MANAGER (SCIENTIFIC), for a 6 MONTHS contract.
Duration: ASAP to 31/12/2018
Location: Basel
Workload: 100%
Major Responsibilities:
- Maintenance of product licences world-wide for the assigned company's' registered product
- Responsible for the operational execution of specific regulatory deliverables relating to world-wide maintenance, upkeep and life cycle management of assigned global portfolio brands.
- Preparation of all necessary supporting documentation for EU license renewals, EU variations, PSUR submissions; addressing HA requests and leading preparation of HA responses; managing interactions with RA colleagues in CPOs, participation in regulatory subteams; preparation of IND/NDA Annual Reports & DSURs.
- Supporting Established Medicines Franchise
- Support GPR Director in addressing compliance-related issues arising on Established Medicines portfolio including input to Urgent Safety Restrictions (USR) and the preparation of internal and external communication documents to the EU HAs involving multiple countries
- Lead/provide input to solve regulatory issues related to assigned registered products
- Lead the HA Response Team through the regulatory maintenance processes. Represent RA in negotiations with HA in EU in liaison with DRA CPOs or Europharm. Provide prompt and complete responses to regulatory relevant queries from various stakeholders (eg HAs, CPOs) relating to assigned brands.
- Manage the interaction with RA colleagues in Country organizations.
- Partner with US GPRM in preparation of IND/NDA Annual Reports and US PI changes driven by CDS update for assigned Established Medicine brands.
Candidate Background:
Languages: Fluent English
Experience:
- Regulatory experience in the pharmaceutical industry
- Experience in regulatory documentation
- Compliance-related experience
- Experience as CRO
- Experience in a global/Matrix environment or cross-functional teams
- Experience in reporting
- Communication skills
Education: University Degree
For further details please contact Aleksandra Sztajerowska:
Tel/E-mail: (see below)
Please note that only selected candidates will be contacted.
For our Client in BASEL, we are looking for a GLOBAL PROGRAM REGULATORY MANAGER (SCIENTIFIC), for a 6 MONTHS contract.
Duration: ASAP to 31/12/2018
Location: Basel
Workload: 100%
Major Responsibilities:
- Maintenance of product licences world-wide for the assigned company's' registered product
- Responsible for the operational execution of specific regulatory deliverables relating to world-wide maintenance, upkeep and life cycle management of assigned global portfolio brands.
- Preparation of all necessary supporting documentation for EU license renewals, EU variations, PSUR submissions; addressing HA requests and leading preparation of HA responses; managing interactions with RA colleagues in CPOs, participation in regulatory subteams; preparation of IND/NDA Annual Reports & DSURs.
- Supporting Established Medicines Franchise
- Support GPR Director in addressing compliance-related issues arising on Established Medicines portfolio including input to Urgent Safety Restrictions (USR) and the preparation of internal and external communication documents to the EU HAs involving multiple countries
- Lead/provide input to solve regulatory issues related to assigned registered products
- Lead the HA Response Team through the regulatory maintenance processes. Represent RA in negotiations with HA in EU in liaison with DRA CPOs or Europharm. Provide prompt and complete responses to regulatory relevant queries from various stakeholders (eg HAs, CPOs) relating to assigned brands.
- Manage the interaction with RA colleagues in Country organizations.
- Partner with US GPRM in preparation of IND/NDA Annual Reports and US PI changes driven by CDS update for assigned Established Medicine brands.
Candidate Background:
Languages: Fluent English
Experience:
- Regulatory experience in the pharmaceutical industry
- Experience in regulatory documentation
- Compliance-related experience
- Experience as CRO
- Experience in a global/Matrix environment or cross-functional teams
- Experience in reporting
- Communication skills
Education: University Degree
For further details please contact Aleksandra Sztajerowska:
Tel/E-mail: (see below)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges