EMD Serono, Inc. is proud to belong to the oldest pharmaceutical and chemical company in the world. With a history spanning more than 300 years, our parent company, Merck KGaA, still operates successfully in both sectors. We are known in the United States as EMD, a name that stands for Emmanuel Merck, Darmstadt, heralding back to our roots in Germany.
Post: Senior Director, Global Regulatory Affairs, Neurodegenerative Diseases
Job Description:
PURPOSE OF THE ROLE
To develop global regulatory strategies for neurodegenerative products.
Lead submission and approval of applications for clinical trials (WW) and marketing applications; full submissions and variations in 3 ICH regions.
Manage a team of regulatory professionals
Represent the company in external forums.
Decision maker on submission readiness
Possible delegate for TA Head.
Functional Tasks
Preparation of regulatory strategies for projects
Review of protocols, reports and all types of regulatory documentation (quality safety efficacy and labeling) CTAs
Decide on submission readiness
Managerial Tasks
Global Project team member
Lead GRA sub-team
Lead a small team of regulatory professionals (up to 4)
Management of the regulatory submission process through to approval, including management and coordination of the preparation of all regulatory documentation
Management of the regulatory agency interactions; document preparation, co-ordination rehearsals and minutes
Develop and manage the local TA Unit budget, if appropriate
Maintain adequate staffing levels to meet resource needs
nsure adequate training and mentoring of employees
MAIN INTERFACES
Interfaces with other Departments/Functions:
All other Development Functions, US Medical, Commercial, Legal, Regulatory Affairs
External Interfaces:
FDA, other EMEA and National Health Authorities as appropriate, CROs, Industry Associations
Desired Profile:
EDUCATION/LANGUAGES
Degree in a Life Science or related discipline, higher degree preferable (Ph.D, M.Sc, MBA)
Excellent spoken and written English
PROFESSIONAL & TECHNICAL SKILLS
Minimum of 10 years industry experience and 8 years regulatory experience, preferably with extensive experience with FDA Division of Neurology.
Experience in preparation and management of full submission or large variation/supplement in at least 2 ICH regions, through to authorization.
Leading regulatory agency interactions including management of the associated documentation and rehearsals, particularly. Successful track record with FDA, preferably with Division of Neurology.
Experience in CTA requirements WW.
Experience in leading special consideration opportunities WW.
Knowledge and successful experience of international regulatory affairs (demonstrated by above).
Development and preparation of successful regulatory strategies.
Management of and experience with maintenance activities in 2 ICH regions.
eCTD experience.
Experience in managing a team of regulatory professionals.
Capability to manage a number and range of projects throughout development.
Speaker outside company and company representative on pharma industry committees.
Additional Information:
Experience: Min. 10 years
Location: US-MA-Rockland
Education: M.Pharm, M.Sc, MBA, Ph.D
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
End Date: 21st Sept., 2011
Job ID: 1101759
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