Regulatory Affairs Specialist（远程职位）

这条招聘信息来自 KMR Search Group，岗位是 Regulatory Affairs Specialist。职位属于「其他职位」类别，完全远程。公司不限制候选人的居住地，在任何地方都可以申请。

公司没有公布具体数字，这一项会在面试时谈定。对工作时间，招聘信息没有提出任何条件。

这个职位通过了自动核查：凡是要求外国工作许可、签证担保、特定国籍，或者必须居住在指定国家的招聘信息，都不会进入列表。

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