Regulatory Affairs Specialist
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Job description
Responsibilities in this position will include:
- Supports preparation andmaintenance of program annual reports, and may support CMC, nonclinical,pharmacovigilance and other routine regulatory programs and other routineregulatory filings.
- Conducts internetsearches on regulatory topics to support development programs, and departmentand company compliance.
- Provides technicalreview of data or reports to be incorporated into regulatory submissions toensure scientific rigor, accuracy, and clarity of presentation.
- Coordinates, prepares,or reviews regulatory submissions for domestic and/or international projects.
- If supporting a marketedproduct, reviews product promotional materials and labeling for compliance withapplicable regulations and policies.
- Communicates withregulatory agencies regarding pre-submission strategies, potential regulatorypathways, as well as clarification and follow-up of submissions underreview.
- Ensures compliance withapplicable regulations and guidelines (e.g., FDA, EMA, ICH).
- Interacts with and mayhave some oversight of vendor/contract research organization activities.
- Escorts governmentinspectors during inspections and provides post-inspection follow-upinformation as requested.
- Interprets regulatoryrules or rule changes and ensures they are incorporated into corporate policiesand procedures as appropriate.
- Assists in writing orupdating standard operating procedures, work instructions, or policies.
- Advises project teams onsubjects such as premarket regulatory requirements, labeling requirements, orclinical study regulatory compliance issues.
- Identifies relevantguidance documents, international standards, or consensus standard and providesinterpretive assistance.
- Participates in internalor external audits.
- Reviews clinicalprotocols to ensure collection of data needed for regulatory submissions.
- Coordinates recall ormarket withdrawal activities as necessary.
- Manages regulatory taskswithin time and budget of approved project plans.
- Qualifications
- Bachelor's degree in arelated field; advanced degree desirable; RAC certification desirable.
- A minimum of two yearsof relevant experience in Regulatory Affairs with drug or therapeutics biologicproducts.
- Working knowledge ofdrug development guidelines and FDA regulations.
- Familiarity with EMA orother OUS regulatory systems.
- Strong organizationalskills to maintain a high level of productivity, innovation, and prioritizationunder tight timelines.
- Excellent oral andwritten communication skills, including the ability to assist with thepreparation of responses to health authority requests
- Strong proficiency withMicrosoft Office suite including Word, Excel, and Power Point as well as AdobeAcrobat
·Creativity andproblem-solving skills
·Good organizational andplanning skills.
- Demonstrated ability toidentify issues and take appropriate actions.
- The ability to build andmaintain professional relationships with management, peers, and subordinates.
·Attention to detailrequired.
Originally posted on Himalayas
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