Similar posts
Senior RA Manager - Strategy
This vacancy has now expired. Please see similar roles below...
Proclinical, in support of our client, are seeking an individual to fill the role of Senior RA Manager, Strategy. The successful candidate will participate in the development and implementation of regulatory strategy for specific programs, and may take the lead on the design and execution of certain sections of regulatory submissions.
Responsibilities
- Manage and implement EU regulatory strategies in support of assigned projects and sub-teams for centrally approved orphan medicinal products and products currently in clinical development.
- Working closing with the regulatory sub-team and cross-functional stakeholders.
- For products in development, primary responsibilities will involve planning, preparation and submission support for EU clinical trial applications, scientific advice procedures, orphan designation requests, and Pediatric Investigation Plans (PIPs)
- Plan, prepare and submit MAA variations, Renewal documents, post-marketing commitment submissions, PSURs and other ad hoc activities in support of maintaining the marketing authorizations.
Skills And Qualifications
- BS and 5+ years of regulatory work experience.
- Experience preparing, submitting, and working closely with EMA.
- Capable of strategic thinking and proposing innovative solutions to regulatory problems.
- Knowledgeable and experienced in interpretation of regulations and guidelines related to drug development.
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 Nicholas Walker at (+1) 646-367-2908 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-NW1
Related jobs
Highly Competitive
Brussels, Belgium
Proclinical is seeking a Professional Services Resource Manager. This role is pivotal in allocating resources to client projects.
Highly Competitive
Brussels, België
Proclinical are representing a medium sized, global biotech who are expanding rapidly due the significant products that are coming through in our clients pipeline.
Up to US$0.00 per annum + Highly Competitive Salary
Princeton, USA
Proclinical is seeking a talented and motivated Director of CMC for a leading biotechnology company located in Princeton, NJ.
Highly Competitive
Brussels, België
Proclinical has been retained by a cutting edge, biopharmaceutical company to appoint a Global Head of Quality for their commercial manufacturing sites.
Highly Competitive
Valais, Switzerland
Proclinical is seeking an Administrative Assistant to work a 12 month contract.
Highly Competitive Salary
Miami, USA
Proclinical Staffing is seeking an Associate Director, Access & Reimbursement - Oncology to join a global pharmaceutical organization.
Up to US$20 per hour + Highly Competitive Salary
Social Circle, USA
Proclinical Staffing is seeking a Warehouse Clerk to join a global pharmaceutical organization.
Highly Competitive
Leiden, Nederland
Proclinical is seeking a Senior Clinical Scientist to join our team. This role is integral to our development organization as we prepare to start clinical development of our Axiomer pipeline.
Highly Competitive Salary
Middletown, USA
Proclinical Staffing is seeking an Operations Manager, Chemical Manufacturing to join a leading healthcare organization.
Highly Competitive Salary
Zebulon, USA
Proclinical Staffing is seeking a Chemist to join a global leading pharmaceutical company.