We are on the lookout for an organized Head Regulatory Affairs Us - With Great Benefits to join our productive team at Confidentialin TalcaConfidentialGrowing your career as a Full Time Head Regulatory Affairs Us - With Great Benefits is a terrific opportunity to develop exceptional skillsConfidentialIf you are strong in problemWe are looking to hire a remarkable Head Regulatory Affairs Us to join our amazing team at Confidentialin TalcaConfidentialGrowing your career as a Full Time Head Regulatory Affairs Us is an awesome opportunity to develop relevant skillsConfidentialWe are a newly licensed, west coastKey requirements and responsibilities:The position will be responsible for all ANDA submissions, with demonstrated ility to write, compile and publish according to the eCTD content,format and specifications, including the bookmarking and hyperlinking of the documents into FDA compliant documents to be submitted via the Electronic Submission Gateway ESG to the FDACoordination and follow- Up with corporate regulatory, Quality and R&D personnel to ensure that all supporting documents and responses are made in the appropriate format to support the company-s projected ANDA filing and approval datesConfidentialility to compile, organize and publish responses to issues, questions and deficiencies presented by FDAResponsible for establishment registration, self- Identification, labeler code request, SPL preparation and drug listing, MA maintenance activitiesResponsible for submission and follow up of controlled correspondence, briefing books as may be required, and all meeting requests with the FDAWillingness to undergo state and federal level background check, if requiredPrior Experience and Competencies:College degree with a specialization in a life scienceConfidential A master-s degree preferredConfidentialPrior credentials in a senior management position in regulatory affairs with direct experience and oversight of all FDA related mattersThe ility to self- Motivate and work efficiently in a remote or small office settingSupervisory level experience is also desirable in one or several of the following work disciplines:Quality assuranceOperations control, supply chainProject managementBenefits of working as a Head Regulatory Affairs Us in Talca:- Learning opportunities- Advancement opportunities- Advantageous packageBenefits of working as a Head Regulatory Affairs Us - With Great Benefits in Talca:- Excellent benefits- Company offers career progression opportunities- Advantageous package
