Regulatory Affairs Manager CMC
Regulatory Affairs Manager CMC
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$ 143224 - 143224
1 Vacancy
Job Description
Career Category
RegulatoryJob Description
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 everbetter 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 Manager CMC Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; re
ports issues to RA CMC product team management.
Key Responsibilities Include:
Generate and execute of global and countryspecific regulatory strategies
Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements submission strategy and regulatory risk assessments
Develop global dossiers for CMC content for initial submissions variations and amendments
Support change management activities
Develop response strategy and respond to health authority questions
Liaise with other functions in development operations and commercial to ensure alignment of global regulatory strategies timing and supply plans
Liaise with local regulatory teams to align on filing strategy
Monitor and as necessary provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system
Follow established department regulatory processes to ensure crossproduct alignment
Win
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
OR
Masters degree and 3 years of directly related experience
OR
Bachelors degree and 5 years of directly related experience
OR
Associates degree and10 years of directly related experience
OR
High school diploma / GED and12 years of directly related experience
Preferred Qualifications
Experience in manufacture testing (QC/QA or clinical) or distribution
Regulatory CMC experience
Thrive
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 wellbeing.
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 salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans and biannual companywide shutdowns
- Flexible work models including remote work arrangements where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen
Application 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.
Salary Range
112345.00 USD 143224.00 USDRequired Experience:
Manager
Employment Type
Full-Time
