Regulatory Affairs Sr Associate

Career Category Regulatory The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company s products meet and maintain regulatory standards They assist in preparing submissions for regulatory agencies keep updated on changes in regulatory legislation and guide various teams within the company to ensure compliance with applicable regulations 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 The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintenance of state and federal licenses for Amgen products across phases of development modality and countries The team member will be responsible for maintaining U S state and federal commercial product licenses and will collaborate with Global CMC Site CMC and Device Regulatory Operations Quality and Supply Chain teams on strategies and activities impacting licensed products Roles Responsibilities Key responsibilities of the Regulatory Affairs Sr Associate include Tracks license status to ensure all are current and effective Communicates requirements to internal Amgen functional teams Obtains supplemental documentation from internal and external partners Prepares reviews and submits license applications and renewals Maintains all State Licensing documentation submissions and interactions with State Authorities Interfaces with State Board of Pharmacy BoP and or Department of Health DoH Completes required annual notifications to FDA What we expect of you We are all different yet we all use our unique contributions to serve patients The professional we seek is a type of person with these qualifications Basic Qualifications Master s degree OR Bachelor s degree and 2 years of manufacture QA QC or regulatory CMC in the Pharmaceutical Biotechnology industry OR Associate s degree and 6 years of manufacture QA QC or regulatory CMC in the Pharmaceutical Biotechnology industry Preferred Qualifications Degree in Life Science discipline Regulatory CMC specific knowledge experience Experience in manufacture testing QC QA or clinical or distribution in Pharmaceutical Biotech industry Working knowledge of US state and or federal licensing requirements 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 In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards Apply now for a career that defies imagination Objects in your future are closer than they appear Join us careers amgen com 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 with 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