Regulatory Affairs CMC Sr Manager
Regulatory Affairs CMC Sr Manager
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$ 179252 - 179252
1 Vacancy
Job Description
Career Category
RegulatoryJob Description
The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and operations authors) coordinate preparation of regulatory filings identification of issues and factors that may implicate a regulatory strategy or activity. The CMC site team are members of CMC product teams. The CMC Site team is also responsible for coordination of sitespecific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative. The CMC site team is the key RA CMC representative on product deviation investigation teams.
Responsible for the strategy and of the sitespecific aspects of the preparation of CMC investigational product amendments and postmarket supplements organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products; acts as key RA CMC representative on product deviation investigation teams participates in site change control teams.
Basic Qualifications:
- Doctorate degree and 2 years of Regulatory & Compliance experience OR
- Masters degree and 6 years of Regulatory & Compliance experience OR
- Bachelors degree and 8 years of Regulatory & Compliance experience OR
- Associates degree and 10 years of Regulatory & Compliance experience OR
- High school diploma / GED and 12 years of Regulatory & Compliance experience
Preferred Qualifications:
- Bachelors degree
- 6 years experience in manufacturing testing (QC/QA or clinical) or distribution in Pharmaceutical/Biotech industry
- Regulatory CMC experience
- Ability to develop solutions to technical and organizational issues in order to improve performance and productivity
- Able to work independently and proactively
- Strong computer skills including word processing database document repository and project management software
- Able to influence vertically and across functional boundaries
- Strong team player with a commitment to customer service
What you can expect of us
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. From our competitive benefits to our collaborative culture well 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 salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans
- Flexible work models including remote and hybrid work arrangements where possible
Apply now
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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.
As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.
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 disability status or any other basis protected by applicable law.
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
152814.00 USD 179252.00 USDRequired Experience:
Manager
Employment Type
Full-Time
