Sr Associate Regulatory Affairs
Sr Associate Regulatory Affairs
Posted on :
05-02-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Title: Sr. Associate Regulatory Affairs
Job Location: Hyderabad Telangana India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level:
Job Description:
Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients Amgen continues to be an entrepreneurial sciencedriven enterprise dedicated to helping people fight serious illness.
Regulatory Affairs Chemistry Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team Regulatory Optimization of Tactical and Strategic Support (ROOTS2) is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development modality and countries.
The ROOTS2 staff member will interface with the Amgen Global Site Biosimilars and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support including leading projects based upon their experience level.
Additional job responsibilities include:
Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients Amgen continues to be an entrepreneurial sciencedriven enterprise dedicated to helping people fight serious illness.
Regulatory Affairs Chemistry Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team Regulatory Optimization of Tactical and Strategic Support (ROOTS2) is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development modality and countries.
The ROOTS2 staff member will interface with the Amgen Global Site Biosimilars and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support including leading projects based upon their experience level.
Additional job responsibilities include:
- Lead submission for annual reports facility registrations facility renewals and product renewals
- Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions
- Preparing submission content plans for CMC submissions including CMC IND/CTAs and amendments new marketing applications facility registration and renewals post‑market supplements/variations product renewals Module 3 baselines and annual report/notifications
- Coordination preparation collection and/or legalization of CMC country specific documents
- Document and archive CMC submissions and related communications in the document management system
- Initiate and maintain CMC product timelines at the direction of product lead
- Interface with the regulatory operations team
- Train staff on select CMC procedures and systems
- Provide report status of activities and projects to teams and department
- Participate in crossfunctional special project teams
- Master’s degree OR
- Bachelor’s degree and 12 years of experience in manufacture QA/QC or regulatory CMC in the Pharmaceutical/Biotechnology industry
- Associate’s degree and 6 years of experience in manufacture QA/QC or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
- High school diploma / GED and 8 years of experience in manufacture QA/QC or regulatory CMC in the Pharmaceutical/Biotechnology industry
- BS degree in Life Science
- Experience in manufacture Process Development Quality Assurance Quality Control or Analytical development
- Regulatory CMC specific knowledge and experience
- Mature project management and organizational skills
- Strong and effective oral and written communication skills
- Experience in Veeva Vault platforms
/jobs/view/1ea0fbdc028efed87c5bcbc774acf6b3
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
