Senior RA Manager Strategy
ProClinical is currently seeking a Senior Manager of Regulatory Affairs Strategy and Intelligence for a pharmaceutical company that develops products to treat iron deficiency anemia in adults. Successful candidate is required to support early to late phase clinical assets. This individual will be responsible for implementing regulatory strategies and assisting in implementing regulatory intelligence strategy for corporate stakeholders.
- Plan and execute an effective regulatory strategy in alignment with the overall clinical development plan
- Provide regulatory leadership, demonstrate expertise and manage the collection of any necessary documents required for regulatory submissions.
- Identify and escalate key information as appropriate with RA and internal stakeholders.
- Provides regulatory representation in a leadership role on project teams and communicates regulatory policy and clarity on regulatory expectations.
Skills and Qualifications
- BS in Life sciences with 5 - 7 years' regulatory experience.
- Experience with regulatory intelligence is strongly recommended.
- Prior regulatory experience in drug development with post-marketing regulatory activities is required
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.