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Vacancy details
Vacancy description:
Job Code:
Manager Regulatory Affairs
Job Title:
Manager Regulatory Affairs
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
Regulatory Affairs
Country:
France
Location:
Any Location
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
05 Jul 2008
Manager Regulatory Affairs
Qualifications: Training & experience
Graduate University degree or Bachelor Degree in life sciences (pharmacy, chemistry, biology, biochemistry) or nutrition.
At least 3-4 years experience in Regulatory Affairs as gained gained within a CRO, pharmaceutical or nutraceutical environment.
In-depth knowledge of applicable regulatory affairs laws, regulations and policies, both national and international.
Management experience is required.
Fluency in English is mandatory.
Must be able to work with all current computer programs.
Key skills and behaviours
Organization skills with the ability to prioritising workload.
Flexibility and Ability to work under pressure in a fast moving environment.
Self-confident, Self-motivated and ability to motivate.
Leadership skills / team- building skills.
Excellent oral and written communication skills.
Responsibilities: The Manager Regulatory Affairs will strategize, plan and execute submissions of varying complexity to the applicable regulatory agency and have an advisory role for sponsors. Financial responsibility of the project lies with its responsibilities. The primary objectives are:
Prepare and submit marketing authorization applications for Regulatory Authorities/Agencies in accordance to current Legislation (MAA, CTD, eCTD), client requirements and deadlines given.
Prepare and submit dossiers for claim justifications for nutraceuticals.
Provide product development guidance to sponsors with drugs and nutraceuticals and prepare development plans.
Act as member of Omnicare Clinical Research "consulting" team.
Ensure appropriate strategies are recommended to sponsors to allow timely completion of development plans and subsequent approvals.
Prepare, coordinate and attend sponsor regulatory agency meetings.
Attend Omnicare/sponsor project team meetings as Regulatory representative for assigned consulting projects.
Responses to objections/questions issued by Regulatory Agencies/Authorities.
Responsible for the finances of the managed projects (budgets, invoices, revenues, forecasts, achievement of the forecasts).
Cooperation with business development: when requested, input for cost estimates.
Department: Regulatory Affairs
Location: Gentilly France
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