Career CategoryRegulatory
Job DescriptionRegulatory Affairs Director - Inflammation and Rare DiseaseWhat you will doLet's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Inflammation and Rare Disease Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.
In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Director is to lead GRTs within Amgen's GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions, and to provide regulatory expertise and guidance to product teams.
Key Responsibilities:- Develop and execute the global regulatory product strategy
- Lead GRTs
- Represent Regulatory on the product team and other key commercialization governance bodies
- Develop Global Regulatory Strategic Plan and provide regulatory input into the product's Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
- Represent GRA on the product team
- Develop registration strategies and plans aimed at achieving regulatory approval and product labeling
- Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
- Lead the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)
- Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)
- Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment
- Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory strategy
- Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood
- Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)
- Attend key regulatory agency meetings which could impact the global product strategy
- Represent Amgen Regulatory on external partnership teams at the product level
What we expect of youWe 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 4 years of regulatory experience in biotech or science
OrMaster's degree and 7 years of regulatory experience in biotech or science
OrBachelor's degree and 9 years of regulatory experience in biotech or science
Preferred Qualifications:- Ability to lead and build effective teams
- Strong communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and mitigate against future strategic issues & uncertainties
- Ability to resolve conflicts and develop a course of action
- Cultural awareness and sensitivity to achieve global results
- Planning and organizing abilities
- Able to prioritize and manage multiple activities
- Ability to make complex decisions and solve problems
- Ability to deal with ambiguity
- Negotiation skills
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
- A 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 plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comSalary Range189,632.45USD -256,561.55 USD
