Regulatory Affairs Specialist, রিমোট পদ

পদটির নাম Regulatory Affairs Specialist, নিয়োগকর্তা KMR Search Group। কাজটি অন্যান্য পদ বিভাগের এবং পুরোপুরি রিমোট। প্রার্থী কোথায় থাকেন তা নিয়ে নিয়োগকর্তার কোনো শর্তই নেই, তাই আপনি যেখানে আছেন সেখান থেকেই আবেদন করতে পারেন।

নিয়োগকর্তা কোনো অঙ্ক প্রকাশ করেননি, বিষয়টি সাক্ষাৎকারে ঠিক হয়। কাজের সময় নিয়ে বিজ্ঞাপনে কোনো শর্ত নেই।

এই পদটি একটি স্বয়ংক্রিয় যাচাই পেরিয়ে এসেছে: যেসব বিজ্ঞাপনে বিদেশি ওয়ার্ক পারমিট, ভিসা স্পনসরশিপ, নির্দিষ্ট নাগরিকত্ব বা নির্দিষ্ট কোনো দেশে বসবাস চাওয়া হয়, সেগুলো এই তালিকায় ওঠে না।

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