Manager, Regulatory Affairs
Company Name:
WorkStaff USA Staffing Agency
This position provides management of regulatory support to the Renal Divisions drug development activities, preparing regulatory submissions and reviewing documentation to support clinical trials.
Oversees and prepares regulatory submissions to FDA, Health Canada and other agencies as required to support the Renal Divisions clinical development; participates in submission teams to provide regulatory input.
Works closely with Regulatory Operations to ensure documents meet technical requirements for electronic submissions.
Support Renal Divisions clinical studies by reviewing documentation (protocols, ICFs, site documentation) for regulatory compliance; participates in study-related activities such as clinical label review, site drug release, as required. Participates as regulatory representative on clinical study teams.
Acts as regulatory liaison for events such as agency meetings; helps prepare team for meetings and controls meeting documentation.
Maintains regulatory submissions in compliance with requirements, including information amendments, annual reports etc as appropriate.
Maintains regulatory files and listings; maintains departmental SOPs and prepares written instructions for departmental activities.
Maintains regulatory expertise by reviewing agency publications, attending courses and conferences, and communicates relevant information to personnel.
Qualifications
Minimum BSc in relevant subject. Advanced degree strongly preferred.
At least 6 years experience in pharmaceutical regulatory affairs, including experience with FDA. Knowledge of Canadian, EU and Latin American procedures an asset.
Two to three years management experience in a regulatory environment.
Expertise in MS Word, Adobe Acrobat, ISI toolbox, electronic document management.
Ability to work independently under general supervision, adapt to changing priorities and manage multiple tasks; good organizational and planning skills.
Strong written, verbal and interpersonal skills.
Strong attention to detail.
We offer a competitive salary and excellent benefits package, including 401k match, paid disability and life insurance, and excellent medical and dental insurance.Estimated Salary: $20 to $28 per hour based on qualifications.
WorkStaff USA Staffing Agency
This position provides management of regulatory support to the Renal Divisions drug development activities, preparing regulatory submissions and reviewing documentation to support clinical trials.
Oversees and prepares regulatory submissions to FDA, Health Canada and other agencies as required to support the Renal Divisions clinical development; participates in submission teams to provide regulatory input.
Works closely with Regulatory Operations to ensure documents meet technical requirements for electronic submissions.
Support Renal Divisions clinical studies by reviewing documentation (protocols, ICFs, site documentation) for regulatory compliance; participates in study-related activities such as clinical label review, site drug release, as required. Participates as regulatory representative on clinical study teams.
Acts as regulatory liaison for events such as agency meetings; helps prepare team for meetings and controls meeting documentation.
Maintains regulatory submissions in compliance with requirements, including information amendments, annual reports etc as appropriate.
Maintains regulatory files and listings; maintains departmental SOPs and prepares written instructions for departmental activities.
Maintains regulatory expertise by reviewing agency publications, attending courses and conferences, and communicates relevant information to personnel.
Qualifications
Minimum BSc in relevant subject. Advanced degree strongly preferred.
At least 6 years experience in pharmaceutical regulatory affairs, including experience with FDA. Knowledge of Canadian, EU and Latin American procedures an asset.
Two to three years management experience in a regulatory environment.
Expertise in MS Word, Adobe Acrobat, ISI toolbox, electronic document management.
Ability to work independently under general supervision, adapt to changing priorities and manage multiple tasks; good organizational and planning skills.
Strong written, verbal and interpersonal skills.
Strong attention to detail.
We offer a competitive salary and excellent benefits package, including 401k match, paid disability and life insurance, and excellent medical and dental insurance.Estimated Salary: $20 to $28 per hour based on qualifications.
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