What are the responsibilities and job description for the Regulatory Operations Manager position at Dale Workforce Solutions?
The ideal candidate for this role is an experienced submission management professional with at least four years of hands-on experience in regulatory operations within the pharmaceutical or biotechnology industry. They should be a subject matter expert in eCTD publishing and submission assembly, comfortable with Veeva Vault RIM, and knowledgeable about submission content plans and validation publishing. Strong planning and timeline negotiation skills are essential, as this person will coordinate with cross-functional teams and manage vendor relationships to ensure timely submissions. The candidate should also be detail-oriented, capable of quality-checking vendor-published submissions, and flexible enough to step in for urgent publishing tasks when needed. Experience with DocuBridge or similar publishing tools is a plus. Minimum of 4 years of relevant experience is required.
Roles & Responsibilities:
" Manage various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans
" Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers
" Serve as primary point of contact between Client's functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in the appropriate system
" Independently remain current on guidance (internal/external) and translate requirements into operational activities
" Effectively represent global submission management expertise on key projects and global workstreams
" Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective
" Contribute to the development of the strategy for communicating with global health authorities
" Represent departmental expertise on global work streams
" Initiate, lead and manage process development and improvement
" Lead information system and software update projects as well as ongoing system validations from a publishing perspective
" Provide technical support for regulatory systems
" Manage relationships with contributing functions and affiliates
Basic Qualifications:
Doctorate degree
OR
Master's degree and 3 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
Bachelor's degree and 5 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
Associate's degree and 10 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
High school diploma / GED and 12 years of [Job Code's Discipline and/or Sub-Discipline] experience
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Roles & Responsibilities:
" Manage various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans
" Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers
" Serve as primary point of contact between Client's functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in the appropriate system
" Independently remain current on guidance (internal/external) and translate requirements into operational activities
" Effectively represent global submission management expertise on key projects and global workstreams
" Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective
" Contribute to the development of the strategy for communicating with global health authorities
" Represent departmental expertise on global work streams
" Initiate, lead and manage process development and improvement
" Lead information system and software update projects as well as ongoing system validations from a publishing perspective
" Provide technical support for regulatory systems
" Manage relationships with contributing functions and affiliates
Basic Qualifications:
Doctorate degree
OR
Master's degree and 3 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
Bachelor's degree and 5 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
Associate's degree and 10 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
High school diploma / GED and 12 years of [Job Code's Discipline and/or Sub-Discipline] experience
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
