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| Associate Director RA MA Open (J#22718) Education: Bachelors Degree Experience: 4 - 9 years Our clients goal is to discover, develop, and commercialize novel therapeutic products, takes a special type of person. If you're passionate about your work, motivated by a challenge, and deeply committed to what you do, you'll find like-minded individuals at this company. Their environment cultivates innovation--empowering those who want to make a contribution, pursue new ideas and expand their minds along the way. Our client provides a culture that lives its values of Respect, Teamwork, Integrity and Commitment, making it a great place to develop professionally. Associate Director Regulatory Affairs Responsibilities: Reporting to the Director of Regulatory Affairs, the manager/senior manager will work with the Director to implement the regulatory strategy to move our products to approval as quickly as possible while remaining in compliance with applicable regulations and guidelines. -Assesses and communicate regulatory requirements for clinical, preclinical and CMC submissions and programs to assure that all development activities are in compliance with applicable regulations and guidelines Refines and contributes to regulatory argumentation for submissions -Plans, prepares and manages timelines for all regulatory documentation including initial INDs, IND amendments, IMPDs, BLAs, MAAs, orphan designations, meeting requests, protocol assistance, etc., ensuring that timings are supportive of the corporate goals -Responsible for completing the quality control of regulatory documentation prior to submission -Participates on project teams or subteams for the planning of activities needed to meet long term corporate objectives -Writes and reviews documentation associated with regulatory submissions -Keeps abreast of and communicates changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions -Supports and participates in the development of Regulatory Department systems and processes -Cooperates and Interacts directly with the regulatory operations function to develop submissions with electronic submission systems and effective paper systems -Cooperates with the RA Team and the cross-functional team to promote an environment of knowledge sharing and team effectiveness -Assist with the development of regulatory training materials and training program -Other duties, as required JOB QUALIFICATIONS -BS, MS or Ph.D. in biological or pharmaceutical science -Three to five years direct regulatory experience in a biotech or pharmaceutical company -Some experience with recombinant therapeutic proteins preferred -Knowledge of US and EU drug and biologics regulations -Experience in one or more of the following areas considered an advantage First hand knowledge of clinical, nonclinical, and CMC documentation requirements Regulatory submissions to the EU, Canada, the US Preparation of a recent NDA, BLA, or MAA CTD and eCTD application requirements and processes CTD format Advertising and promotion ROW marketing applications -Excellent written and oral communications skills -A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments -Good interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments | |||
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