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About our client
Our client is dedicated to improving and preserving human life by developing innovative pharmaceutical products. The company’s premier product has been developed for delaying/preventing renal flares. Treatment for various other autoimmune and inflammatory conditions have also been developed by the company.
Position	Location
Senior Regulatory Affairs Associate	California
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Prepare document packages for submission to regulatory agencies 2) Compile materials required in clinical trial applications, new drug applications, amendments and annual report submissions 3) Participate in the review and compilation of materials required in submission to IND, DMF and registration applications, including clinical protocols and reports 4) Assess impact of chemistry, manufacturing and control changes to regulatory filings 5) Support Clinical Operations in the review of essential documents required for shipment of clinical trial materials to investigational sites 6) Participate in the development and review of informed consent forms 7) Serve as a regulatory affairs representative on Project Teams 8) Interact with regulatory agencies on defined matters 9) Practice regulatory research support across all disciplines 10) Maintain product chronologies 11) Oversee and ensure compliance with facility licensing requirements/renewals 12) Maintain central archive of regulatory submissions and government agency communications in paper and electronic form 13) Contribute to the development of SOPs, guidelines and policies 14) Keep abreast of regulatory procedures and changes
Requirements
1) Master’s degree or equivalent with a minimum of 2 – 5 years of demonstrated working knowledge of scientific and regulatory principles experience 2) Bachelor's degree or equivalent with preferably a strong science background relevant to drug development 3) Minimum 5 – 8 years of related regulatory experience 4) RAC certification preferred 5) Global regulatory experience preferred 6) Experience in NDA and MAA 7) Experience in lupus/arthritis or inflammatory disease/immunology preferred