Senior Associate - Regulatory Affairs job at Amgen in US National
Senior Associate - Regulatory Affairs
remote type
Remote
locations
United States - Remote
time type
Full time
job requisition id
R-246261
Career Category
Regulatory
Job Description
R-246261 Senior Associate - Regulatory Affairs
What you will do
Let’s do this. Let’s change the world. In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions
To assist the Global Regulatory Lead to manage GRT interactions
Key responsibilities include:
Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
Create and maintain product regulatory information and history documents through Amgen systems
Appropriately archive regulatory documents and agency communications
Collaborate with CRO’s / partners to support site initiation
Complete regulatory forms to support agency communications
Participate in GRT to support execution of regulatory strategy
Coordinate QC of regulatory documentation (e.g. briefing materials)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Assist in template development and maintenance
Respond to specific requests from and communicate relevant issues to GRT
Actively support regulatory compliance
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 self-starter with these qualifications.
Basic Qualifications:
Master’s degree
Or
Bachelor’s degree and 2 years of Regulatory Affairs experience
Or
Associate’s degree and 6 years of Regulatory Affairs experience
Or
High school diploma / GED and 8 years of Regulatory Affairs experience
Preferred Qualifications:
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to collaborate with team members to tackle problems and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and balance multiple activities
Ability to deal with ambiguity
Ability to influence others
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 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.
Salary Range
83,974.90USD -113,613.10 USD
remote type
Remote
locations
United States - Remote
time type
Full time
job requisition id
R-246261
Career Category
Regulatory
Job Description
R-246261 Senior Associate - Regulatory Affairs
What you will do
Let’s do this. Let’s change the world. In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions
To assist the Global Regulatory Lead to manage GRT interactions
Key responsibilities include:
Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
Create and maintain product regulatory information and history documents through Amgen systems
Appropriately archive regulatory documents and agency communications
Collaborate with CRO’s / partners to support site initiation
Complete regulatory forms to support agency communications
Participate in GRT to support execution of regulatory strategy
Coordinate QC of regulatory documentation (e.g. briefing materials)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Assist in template development and maintenance
Respond to specific requests from and communicate relevant issues to GRT
Actively support regulatory compliance
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 self-starter with these qualifications.
Basic Qualifications:
Master’s degree
Or
Bachelor’s degree and 2 years of Regulatory Affairs experience
Or
Associate’s degree and 6 years of Regulatory Affairs experience
Or
High school diploma / GED and 8 years of Regulatory Affairs experience
Preferred Qualifications:
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to collaborate with team members to tackle problems and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and balance multiple activities
Ability to deal with ambiguity
Ability to influence others
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 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.
Salary Range
83,974.90USD -113,613.10 USD