Regulatory Affairs Manager – Regional Regulatory Lead

Categorie: Regulatory
Job ID: R-35888
Locatie: Thousand Oaks, CA
Geplaatst Date: March 20, 2017
The purpose of this role is:
To achieve the desired labeling by developing and executing US regulatory strategies. Execution of the US regulatory strategy includes:
-Planning and managing regulatory submissions (e.g. clinical trial and marketing applications/variations) for
-Products in compliance with global filing plans and local regulatory requirements
-Ensuring that Amgen acquires and maintains all the licenses in order to support clinical trials for investigational and marketed products in the US
To ensure regulatory compliance
To manage effective US regulatory agency interactions

Strategy and Execution
Execute the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US
Provide content for and coordinate US regulatory documents and meetings in accordance with GRT strategy (eg, responses to regulatory agency questions)
Under general supervision, develop US regulatory strategies

Communicate US regulatory strategy
Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line management
Under general supervision, develop regulatory risks and predictions of interactions with regulatory agencies
Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments)
Provide regulatory guidance on US regulatory mechanisms to optimize product development (e.g. orphan drug, fast track, early access, pediatric plan)

Exchange regulatory information with GRT and cross-functional colleagues on an ongoing basis and provide advice on regional considerations
Communicate and ensure alignment of regional management before GRT strategy decisions
Partner with regional management and peers to ensure consistency in procedures and agency interactions

Regulatory Research
Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
Perform regulatory research to obtain relevant histories, precedence and other information relevant to product advancement in the US
Under supervision evaluate and communicate impact of relevant US regulations, guidances, current regulatory environment and competitor labeling

Health Authority Interactions
With general supervision, serve as point of contact and develop relationships with points of contact at the FDA on specific product assignment
Document and communicate details and outcomes of FDA interactions to GRT and relevant sr. management
Under general supervision, participate in core regulatory activities to ensure effective FDA interactions consistent with the Global Regulatory strategy—includes contingency regulatory planning/risk assessment

Region Specific Activities
Manage the development of the US product label by collaborating with the Labeling Working Group in the context of available and expected scientific data, regulatory guidance and precedent; support label negotiations
Advise and support promotion group regarding applicability of data for product communication in the US
Keep regulatory intelligence tool(s) current


Basic Qualifications

Doctorate degree
Master’s degree and 3 years of experience in regulatory or pharmaceutical drug development
Bachelor’s degree and 5 years of experience in regulatory or pharmaceutical drug development
Associate’s degree and 10 years of experience in regulatory or pharmaceutical drug development
High school diploma / GED and 12 years of experience in regulatory or pharmaceutical drug development

Preferred Qualifications

Regulatory submissions experience (eg, INDs or CTAs)
Experience interacting with regulatory agencies

Knowledge of regulatory principles

Working with policies, procedures and SOPs

Knowledge of national legislation and regulations relating to medicinal products

Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals

Knowledge of drug development

Team work

Communication skills – both oral and written

Ability to understand and communicate scientific/clinical information

Knowledge of and experience in regional regulatory environment in relevant product area and development stage

Understanding of regulatory activities and their touch points

Ability to resolve conflicts and develop a course of action leading to a beneficial outcome

Cultural awareness and sensitivity to achieve results across both regional country and International borders

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.