Regulatory Manager
This vacancy has now expired. Please see similar roles below...
Proclinical is seeking a Manager to represent Regulatory Affairs for pharmaceutical development projects and marketed products. Successful candidate develop and communicate regulatory strategy on project teams and will work with development teams, identify and compile required documentation for regulatory submissions.
Responsibilities
- Ensure technical accuracy and regulatory compliance of all submissions for assigned projects are executed appropriately and submitted on time.
- Compile information into regulatory documents in consultation with subject matter experts.
- Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact company products and operations.
- Work with manager, effectively plan, organize, and participate in formal meetings with regulatory agencies as assigned.
- Supervise contractors as assigned for regulatory projects; collaborate on marketing application maintenance across multiple geographies and across business units as assigned.
Skills and Qualifications
- BS degree or equivalent in a scientific field.
- 6+ years' experience in Regulatory Affairs.
- Computer literate with knowledge of Microsoft Suite.
- Advanced knowledge of US and ICH regulations.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-NA1
Related jobs
Highly Competitive Salary
München (81249), Deutschland
Proclinical sucht einen engagierten regionalen Vertriebsleiter für die Osthälfte Deutschlands im Bereich Urologie.
Highly Competitive
Deutschland
Proclinical are currently in search of a dynamic Statistical Project Leader.
Highly Competitive
Tuttlingen, Germany
Proclinical sucht einen Systems Engineer - Instruments für einen Kunden aus der Medizintechnik-Branche.
Highly Competitive
Singapore River, Singapore
Proclinical are recruiting for a Senior eCommerce Manager APAC (6 months maternity cover) to join a pharmaceutical organisation.
Highly Competitive
Tuttlingen (78532), Deutschland
Proclinical auf der Suche nach einem Systems Engineer (m/w/d).
Highly Competitive
Singapore
Proclinical is seeking a dedicated Automation Engineer to provide technical support for smooth manufacturing operations.
Highly Competitive Salary
Lexington, USA
Proclinical is seeking a dedicated Project Manager to lead IT projects within business applications and IT infrastructure. This is a contract position located in Lexington, MA.
Highly Competitive Salary
Indianapolis, USA
Proclinical is seeking a dedicated and innovative Electrical Engineer to join our Engineering Operations Team. This is a permanent position located in Indianapolis, IN.
Highly Competitive Salary
New Haven, USA
Proclinical is actively seeking an Upstream Associate Scientist. This is a contract position located in New Haven, CT.
Highly Competitive Salary
Boston, USA
Proclinical Staffing is seeking a Senior Director, of Antibody Bioconjugate Discovery to join an innovative biotech developing next generation neurogenetic medicines.