Regulatory Affairs Manager II - Real Staffing (thousand oaks, california)
Overview:
:
Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders Key Activities Strategy and Execution :
Plans and manages regulatory submissions (e.
g.
clinical trial and marketing applications) for products within Amgens portfolio in compliance with global filing plans and local regulatory requirements.
:
Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
:
Under general supervision participate in the development, and execution of regional regulatory product strategies, including precedence, risk management and contingency planning :
Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives :
Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs) :
Communicates regulatory strategies within team (e.
g.
GRT, local affiliates) :
Works with line management to estimate the likelihood of regulatory success based on proposed strategies and communicates to GRT :
Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies Additional Qualifications :
Under general supervision participates in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy:
includes contingency regulatory planning/risk assessment Source:
.
Estimated Salary: $20 to $28 per hour based on qualifications.
:
Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders Key Activities Strategy and Execution :
Plans and manages regulatory submissions (e.
g.
clinical trial and marketing applications) for products within Amgens portfolio in compliance with global filing plans and local regulatory requirements.
:
Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
:
Under general supervision participate in the development, and execution of regional regulatory product strategies, including precedence, risk management and contingency planning :
Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives :
Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs) :
Communicates regulatory strategies within team (e.
g.
GRT, local affiliates) :
Works with line management to estimate the likelihood of regulatory success based on proposed strategies and communicates to GRT :
Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies Additional Qualifications :
Under general supervision participates in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy:
includes contingency regulatory planning/risk assessment Source:
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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