Associate Director
Eli Lilly and Company seeks an Associate Director to work in collaboration with Nonclinical, Manufacturing/CMC, Program Management, and Executive Leadership teams, to develop and coordinate global regulatory operations for multiple programs globally.
Manage regulatory vendors, direct the planning and completion of regulatory dossiers, and manage/store all interactions with Health Authorities.
Collaborate with cross-functional teams and vendors to create, orchestrate, maintain, and communicate regulatory project resources and timeline estimates that support multi-country submissions.
Create/maintain templates and/or procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentations.
Support regulatory documentation contributors and serve as regulatory affairs submissions lead to project teams.
Act as technical submissions expert with competency in the use of submissions publishing tools.
Serve as business process owner for Regulatory Information Management System (RIM) and assist with Trial Master File (TMF) as necessary.
Contribute to the identification of potential issues/gaps and propose creative risk mitigation strategies to address gaps affecting optimal and timely submissions/approvals.
Assist the regulatory affairs team in the determination of submission strategy.
Track changing global regulatory requirements, including health authority guidelines, regulatory policies, and overall environment relevant for gene therapies.
Work with the Regulatory Affairs team, to assess and communicate regulatory requirements to our organization to ensure development activities are in compliance with applicable regulations and guidelines.
May supervise up to three employees holding job titles of:
Regulatory Operations Specialist, Associate Manager, and Regulatory Publisher.
Telecommuting permitted from anywhere in the U.
S.
Reports to the NYC office.
Travel required:
25% to travel monthly to the NYC office.
Position requires a Bachelor's degree in Life Sciences, Genetics, Biochemistry, Biology, Microbiology, Virology, Neuroscience, Medicine, Regulatory Affairs, or related, and 5 year of Regulatory affairs operations for drug or biologics.
Alternatively, this position will accept a Master's degree in Life Sciences, Genetics, Biochemistry, Biology, Microbiology, Virology, Neuroscience, Medicine, Regulatory Affairs, or related, and 3 year of Regulatory affairs operations for drug or biologics.
Experience must include a minimum of:
1) CTD and eCTD format and regulatory submission requirements to different regulatory agencies; 2) Preparation and maintenance of global regulatory dossiers, including INDs, CTAs, NDAs, BLA/MMA, IMPDs, amendments, annual reports, responses to health authority; 3)Managing multiple projects and communicating with all involved parties; 4) Management of CROs, vendors and consultants; 5) GXPs and ICH guidelines in clinical trials; 6) eCTD Manager Publishing tool, ISI Toolbox, Lorenz evalidator for document publishing; 7) eCTDXpress publishing tool; and 8) Veeva RIM Regulatory Information Management Software.
Job location:
New York, NY.
To apply, please visit https:
//jobsearch.
lilly.
com/ and enter job requisition number R-52444 when prompted.
Alternatively, please send your resume, cover letter, and a copy of the ad to:
Beth L.
Berry, Lilly Corporate Center, Indianapolis IN 46285.
Recommended Skills Biochemistry Biology Business Informatics Clinical Trials Communication Genetics Estimated Salary: $20 to $28 per hour based on qualifications.
Manage regulatory vendors, direct the planning and completion of regulatory dossiers, and manage/store all interactions with Health Authorities.
Collaborate with cross-functional teams and vendors to create, orchestrate, maintain, and communicate regulatory project resources and timeline estimates that support multi-country submissions.
Create/maintain templates and/or procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentations.
Support regulatory documentation contributors and serve as regulatory affairs submissions lead to project teams.
Act as technical submissions expert with competency in the use of submissions publishing tools.
Serve as business process owner for Regulatory Information Management System (RIM) and assist with Trial Master File (TMF) as necessary.
Contribute to the identification of potential issues/gaps and propose creative risk mitigation strategies to address gaps affecting optimal and timely submissions/approvals.
Assist the regulatory affairs team in the determination of submission strategy.
Track changing global regulatory requirements, including health authority guidelines, regulatory policies, and overall environment relevant for gene therapies.
Work with the Regulatory Affairs team, to assess and communicate regulatory requirements to our organization to ensure development activities are in compliance with applicable regulations and guidelines.
May supervise up to three employees holding job titles of:
Regulatory Operations Specialist, Associate Manager, and Regulatory Publisher.
Telecommuting permitted from anywhere in the U.
S.
Reports to the NYC office.
Travel required:
25% to travel monthly to the NYC office.
Position requires a Bachelor's degree in Life Sciences, Genetics, Biochemistry, Biology, Microbiology, Virology, Neuroscience, Medicine, Regulatory Affairs, or related, and 5 year of Regulatory affairs operations for drug or biologics.
Alternatively, this position will accept a Master's degree in Life Sciences, Genetics, Biochemistry, Biology, Microbiology, Virology, Neuroscience, Medicine, Regulatory Affairs, or related, and 3 year of Regulatory affairs operations for drug or biologics.
Experience must include a minimum of:
1) CTD and eCTD format and regulatory submission requirements to different regulatory agencies; 2) Preparation and maintenance of global regulatory dossiers, including INDs, CTAs, NDAs, BLA/MMA, IMPDs, amendments, annual reports, responses to health authority; 3)Managing multiple projects and communicating with all involved parties; 4) Management of CROs, vendors and consultants; 5) GXPs and ICH guidelines in clinical trials; 6) eCTD Manager Publishing tool, ISI Toolbox, Lorenz evalidator for document publishing; 7) eCTDXpress publishing tool; and 8) Veeva RIM Regulatory Information Management Software.
Job location:
New York, NY.
To apply, please visit https:
//jobsearch.
lilly.
com/ and enter job requisition number R-52444 when prompted.
Alternatively, please send your resume, cover letter, and a copy of the ad to:
Beth L.
Berry, Lilly Corporate Center, Indianapolis IN 46285.
Recommended Skills Biochemistry Biology Business Informatics Clinical Trials Communication Genetics Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
