ProClinical is currently seeking a Regulatory Liaison for a pharmaceutical company that develops products to treat iron deficiency anemia in adults. Successful candidate will be mentored by senior regulatory professionals to become proficient in the interactions with US and RoW health authorities and working in cross-functional development teams.
- Assist in development of global regulatory strategies.
- Liaise and assist with global regulatory authorities to manage communications and operations.
- Assist with clinical development plans and regulatory strategic plans, to the project team.
- Assist the preparation of regulatory submissions including pre-IND and formal meeting requests with FDA, Annual reports and routine correspondence.
- Monitor and oversees clinical trial activities for regulatory compliance and practices.
- Assist in providing regulatory intelligence for cross-functional project teams.
- Assist in regulatory review, feedback and/or approval for relevant documents.
- Interact with company partners and consultants for various regulatory matters as needed.
- Coordinate timely submissions to FDA and other health authorities.
- Assist with logging, tracking and filing of correspondence and submission to/from regulatory authorities.
- Prepare and writes regulatory documents for submissions.
- Monitor applicable current and new regulatory requirements.
- Help to prepare plan and internal SOP's to manage regulatory compliance and reporting requirements.
Skills and Requirements
- BS or MS in relevant field and 3+ years of overall experience in the pharmaceutical industry. Advanced degree (PhD, PharmD) is a plus.
- Knowledge of FDA regulatory requirements and IND applications, experience in Pharmacovigilance is a plus.
- Experience with multiple Health Authorities interactions and Scientific Advice proceedings.
- Experience working in cross-functional teams, participating in team discussions to resolve and reach agreement on project issues.
- Excellent written and oral communication skills.
- Knowledge in CNS disease area and Orphan Diseases is preferred.
- Travel: Approximately 10% domestic and international travel for meetings with health authorities and conferences.
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.
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