We apologize for the inconvenience but the job you are looking for has been filled or it has been removed by the recruiter. For your reference, the original listing is shown at the bottom of this page.
Listed below are the top 10 out of 14 listings that are in the same industry and location as the job you were looking for. To see more than 10 listings, click here to search similar jobs in Thousand Oaks, CA
The RA CMC Group is responsible for generation of the global regulatory strategy and providing feedback to the team for plans and execution of the strategy. ...
This role leads the Bone Therapeutic Area team within Amgen's Regulatory Affairs department. The Therapeutic Area Head (TAH) manages a team responsible for ...
To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global ...
Group Purpose: To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation ...
The successful Director of Design Assurance (DA) will lead and build a dynamic team that supports all new product development across the organization. In this ...
The purpose of this role is to facilitate registration of Amgen products in Asia, with a focus on China, through executing our international expansion plans; ...
The purpose of this group is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development ...
The purpose of this group is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development ...
GRAAS Biosimilar Policy is accountable for defining Amgen positions on the scientific, medical and regulatory aspects of biosimilars and advocating those standards ...
Biosimilars are an important new development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies ...
For your reference, we have included the original job posting below.
Regulatory Affairs Director (Global Regulatory Leader)
Job Number:
39985207
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Science & Biotech Healthcare & Medical
Regulatory Affairs Director (Global Regulatory Leader)
The Therapeutic Area team facilitates product development and global registration to achieve the desired regional labeling by developing and executing regulatory strategies and effective regulatory agency interactions.
The Global Regulatory Leader (GRL) will lead one or more programs in the Therapeutic Area team within Amgen's Regulatory Affairs department.
Key Activities: - Participate in the development of product label and core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent - Develop global Regulatory Plan through integration of regional regulatory strategies and provide regulatory input into the global Strategic Plan - Provide input into SCD, study protocols, statistical analysis plans, clinical study reports and other documents used to support product development and registration - Provide leadership for planning and implementing regulatory filings i.e. FIH, CTD, label extensions - Ensure effective regulatory agency communications by chairing core regulatory and cross functional teams - Ensure consistent communication of information to all ethics committees and Health Authorities - Ensure global consistency of evidence based product communication - Ensure effective regulatory agency communications by chairing core regulatory and cross functional teams - Lead GRT to develop and execute team goals - Provide education and training on regulatory strategies and compliance issues to other PST functions - Collaborate with PST to develop product registration strategies and development plans aimed at achieving regulatory approval and product labeling - Conduct contingency regulatory planning/risk assessment for product development strategies and agency interactions - Monitor and assess impact of relevant global regulations, guidance, current regulatory environment and competitor labeling - Provide guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional approval, compassionate use and pediatric plan) - Ensure creation and maintenance of product regulatory history documents through IMR and appropriate archiving of all regulatory documents and agency communication
Basic Qualifications - Doctorate degree & 4 years of directly related experience OR - Master's degree & 8 years of directly related experience OR - Bachelor's degree & 10 years of directly related experience
Preferred Qualifications - Regulatory submissions experience - Experience interacting with regulatory agencies - Oncology Therapeutics Knowledge and Skills - Demonstrated ability to lead a team - Strong communication skills - both oral and written - Ability to understand and communicate scientific/clinical information
