Regulatory Affairs Manager - Puerto Rico
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The Regulatory Affairs Manager role will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans. Primary responsibilities include develop regulatory strategies for reporting post approval changes, preparation of critical CMC submission documentation, assessment of change control, non-conformances and other quality related documents, and the preparation of the annual report of minor changes. Participate in general regulatory affairs and regulatory compliance functions of the company.
SPECIFIC RESPOSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Develop and execute CMC related regulatory strategies support the introduction of new products to the site and for manufacturing related post-approval changes.
Serve as the regulatory CMC representative on specific project teams. Provide team with guidance on regulatory requirements.
Support the preparation and responses for global marketing applications and regulatory submissions related to changes at the site. Review and assess the regulatory impact of proposed manufacturing related changes, nonconformance events and other GMP related documents.
Lead the preparation of the Annual Report of Minor Changes for approved products manufactured at the site.
Review and assess the regulatory impact of proposed manufacturing related changes, non-conformance events and other GMP related documents.
Support the generation of facility and GMP related document to support emerging market registrations.
Provide regulatory expertise and policy support for good industry practices (GMPs)
Develop and maintain regulatory awareness through meetings, conferences and regulatory contacts
BASIC EDUCATION & EXPERIENCE
Doctorate degree in Life Sciences
Master’s degree in Life Sciences and 3 years of experience in pharmaceutical or biotechnology manufacturing environment.
Bachelor’s degree in Life Sciences and 5 years of experience in pharmaceutical or biotechnology manufacturing environment.
Educational background in Biology, Chemistry or Biochemistry
Regulated industry, GMP experience
Understanding of drug development or drug commercial process
Experience in the development, review and maintenance of global regulatory dossiers.
Ability to review regulatory documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
Ability to communicate with corporate business functions and internal business partners.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
Successfully work within a team/partnership environment
Leadership and strong communication skills
Fundamental project management skills
Experienced in process improvement methodologies
Good analytical problem solving skills
Strong communication skills - oral and written (English and Spanish)
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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, or disability status.