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Global Program Regulatory Manager (GPRM) (Ref: PD1976)
Eingestellt von BRINE SA
Gesuchte Skills: Consultants, Sap
Projektbeschreibung
GLOBAL PROGRAM REGULATORY MANAGER (GPRM)
JOB PURPOSE:
The GPRM works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT)
representative and/or GTAL for programs through development, registration and approval/post approval. The GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the DRA GPT representative and/or GTAL. In certain cases, the GPRM may act as the GPT representative. The GPRM is a member of the DRA subteam and may indirectly report to the DRA GPT representative for the project and may have responsibility for leading regional DRA subteams.
EDUCATION:MINIMUM/DESIRABLE:
Science based BS or MS with requisite experience and demonstrated capability.
Advanced degree (MD, Ph D, PharmD) preferred.
LANGUAGES:
Fluency in English as a business language. Additional language is an asset.
REQUIRED EXPERIENCE:
Experience with regulatory submission and approval processes in 1 or more major regions.
Experience in a global/Matrix environment or cross-functional teams in the pharmaceutical industry.
Experience in HA negotiations.
2 - 4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas:
- Innovation in regulatory strategy.
- Understanding of post-marketing/brand optimization strategies and commercial awareness preferred.
- Involvement in any dossier submissions and approvals
- HA negotiations.
- Drug regulatory submission and commercialization in region.
- Analysis and interpretation efficacy and safety data.
- Regulatory operational expertise.
SKILLS:
Strong interpersonal, communication, negotiation and problem solving skills.
Basic organizational awareness (eg, interrelationship of departments, business priorities).
To learn more about this opportunity please send your CV ASAP in Word format to Brine SA.
WORK LOCATION: Basel
START: ASAP - 28.02.2017
DURATION: 10 months +
PERMITS REQUIRED: EU citizen or valid work permit
WORKLOAD: 100%
REF: PD1976
BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:
Financial services sector, especially banks and insurance companies
Pharmaceutical industry
Government and services sectors
BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.
IT - RESOURCES
We offer our top consultants, computer profis and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions.
BRINE SA is especially distinguished by its renowned characteristic strengths:
Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements
Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA
Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment
BRINE SA is ISO 9001:2008 certified since 2012
JOB PURPOSE:
The GPRM works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT)
representative and/or GTAL for programs through development, registration and approval/post approval. The GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the DRA GPT representative and/or GTAL. In certain cases, the GPRM may act as the GPT representative. The GPRM is a member of the DRA subteam and may indirectly report to the DRA GPT representative for the project and may have responsibility for leading regional DRA subteams.
EDUCATION:MINIMUM/DESIRABLE:
Science based BS or MS with requisite experience and demonstrated capability.
Advanced degree (MD, Ph D, PharmD) preferred.
LANGUAGES:
Fluency in English as a business language. Additional language is an asset.
REQUIRED EXPERIENCE:
Experience with regulatory submission and approval processes in 1 or more major regions.
Experience in a global/Matrix environment or cross-functional teams in the pharmaceutical industry.
Experience in HA negotiations.
2 - 4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas:
- Innovation in regulatory strategy.
- Understanding of post-marketing/brand optimization strategies and commercial awareness preferred.
- Involvement in any dossier submissions and approvals
- HA negotiations.
- Drug regulatory submission and commercialization in region.
- Analysis and interpretation efficacy and safety data.
- Regulatory operational expertise.
SKILLS:
Strong interpersonal, communication, negotiation and problem solving skills.
Basic organizational awareness (eg, interrelationship of departments, business priorities).
To learn more about this opportunity please send your CV ASAP in Word format to Brine SA.
WORK LOCATION: Basel
START: ASAP - 28.02.2017
DURATION: 10 months +
PERMITS REQUIRED: EU citizen or valid work permit
WORKLOAD: 100%
REF: PD1976
BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:
Financial services sector, especially banks and insurance companies
Pharmaceutical industry
Government and services sectors
BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.
IT - RESOURCES
We offer our top consultants, computer profis and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions.
BRINE SA is especially distinguished by its renowned characteristic strengths:
Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements
Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA
Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment
BRINE SA is ISO 9001:2008 certified since 2012
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Organisation/Management