Regulatory Affairs Senior Manager Regional Regulatory Lead

1 month ago

Washington DC, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.Regulatory Affairs Senior Manager Regional Regulatory Lead

Live

What you will do

Lets do this. Lets change the world. The Regulatory Affairs Senior Manager at Amgen ensures the companys compliance with all regulations and laws pertaining to the companys business. They work with federal, state, and local regulatory agencies on issues and regulations that affect the companys products and services. In this vital role you will achieve the desired labeling by developing and implementing US regulatory strategies.Responsibilities:

Implement the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the USProvide content for and coordinate US regulatory documents and meetings in accordance with GRT strategy (eg, responses to regulatory agency questions)Develop US regulatory strategiesEstimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line managementDevelop regulatory risks and predictions of interactions with regulatory agenciesEnsure 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 considerationsCommunicate and ensure alignment of regional management before GRT strategy decisionsPartner with regional management and peers to ensure consistency in procedures and agency interactionsMaintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.Perform regulatory research to acquire relevant histories, precedence and other information relevant to product advancement in the USUnder supervision evaluate and communicate impact of relevant US regulations, guidances, current regulatory environment, and competitor labelingWith general supervision, serve as point of contact and develop relationships with points of contact at the FDA on specific product assignmentDocument and communicate details and outcomes of FDA interactions to GRT and relevant Sr. managementUnder general supervision, participate in core regulatory activities to ensure effective FDA interactions consistent with the Global Regulatory strategyincludes contingency regulatory planning/risk assessmentManage 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 negotiationsConsults with and supports promotion group regarding applicability of data for product communication in the USKeep regulatory intelligence tool(s) currentWin

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.Basic Qualifications:

Doctorate degree and 2 years of experience in regulatory or pharmaceutical drug development

Or

Masters degree and 4 years of experience in regulatory or pharmaceutical drug developmentOr

Bachelors degree and 6 years of experience in regulatory or pharmaceutical drug developmentOr

Associates degree and 10 years of experience in regulatory or pharmaceutical drug developmentOr

High school diploma / GED and 12 years of experience in regulatory or pharmaceutical drug developmentPreferred Qualifications:

Regulatory submissions experience (eg, INDs or CTAs)Experience interacting with regulatory agenciesKnowledge of regulatory principlesWorking with policies, procedures, and SOPsKnowledge of national legislation and regulations relating to medicinal productsAwareness of the registration procedures in region for MA, post approval changes, extensions, and renewalsKnowledge of drug developmentTeamworkCommunication skills - both oral and writtenAbility to understand and communicate scientific/clinical informationKnowledge of and experience in regional regulatory environment in relevant product area and development stageUnderstanding of regulatory activities and their touch pointsAbility to resolve conflicts and develop a course of action leading to a beneficial outcomeCultural awareness and sensitivity to achieve results across both regional country and international bordersThrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.comApplication deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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