Work as a Senior Director, Global Regulatory Affairs, Neurodegenerative Diseases @ EMD Serono, Division of Merck & Co. | US-MA-Rockland

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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

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