• United States Of America, Usa
  • Save Job
  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

This position will provide Regulatory Affairs CMC strategy and tactical elements of regulatory submissions for approved biologic products This role will actively partner with regulatory therapeutic area counterparts to establish alignment with product regulatory strategies and to communicate Regulatory Affairs CMC documentation requirements to team members both internally and externally with a focus on lot distribution reports This manager position is specifically responsible for providing support in the collection, evaluation, preparation, and assembly of documentation required for US and international (ex-US) submissions to support both original marketing applications and maintenance of existing licenses for marketed products

Assist in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components (forms, cover letter, etc)
Assist with the establishment of submission timelines and management of information required to meet submission target dates
Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications
Ensure proper maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, timelines, and deliverables
Research relevant information, regulations, and guidance from different regulatory agencies
Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination
Assist in the preparation of agendas, presentations, and other supporting materials for various meetings
Author regulatory SOPs, Guidelines, and Toolkits
Provide management updates and project reports as required
Assist senior regulatory staff in collating and addressing regulatory submission review comments
Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required
Support senior regulatory staff in performing regulatory review and evaluation of CMC changes that may impact existing or pending international regulatory files
Proactively identify potential issues and alert supervisor for further action

Essential
BS/MS in a scientific discipline
Ability to multi-task; excellent planning and organizational skills with attention to detail and accuracy
Strong interpersonal and communication (oral and written) skills
Computer savvy; competent with common computer applications, such as MS Word, Acrobat, PowerPoint, Project, and Excel; and comfortable working with document management and other electronic submission systems
Self-motivated and require minimum supervision when performing routine job functions
Eager to learn relevant scientific knowledge and new regulatory requirements

Desirable
Experience working with approved biologics is preferred
Experience with firstdoc based documentation management systems
Quality Assurance experience orTechnical experience in the testing or manufacture of biotechnology-derived products or complex biologics

AstraZeneca embraces diversity and equality of opportunity We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills We believe that the more inclusive we are, the better our work will be We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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