REGULATORY MANAGER - PHARMACEUTICAL - BIOTECH - EXCITING NEW OPPORTUNITY!

My client is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting.The candidate will be responsible for providing regulatory support to project teams and managing regulatory documentation and information.  Responsibilities include management of IND and CTA submissions in the US and EU, and performing regulatory activities in the preparation of NDAs and MAAs. Principal Duties and Responsibilities· Provide regulatory research, as well as regulatory assistance to the project team, in support of ongoing efforts towards gaining marketing authorization for company's products. Review critical documents (i.e. labeling, protocols, ICFs) for submission to health authorities, in order to confirm adherence to recognized standards and appropriate regulations and procedures. Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines. Represent Regulatory Affairs at various project team and working group meetings. Contribute to the development of regulatory strategy plans.· Manage submission activities (IND/CTA, trial maintenance, NDA/MAA) and health authority interactions (meeting requests and briefing documents) Ensure the quality and content of all submissions to health authorities Provide guidance and direction to junior level regulatory employees.  Minimum Qualifications· Minimum 5 years regulatory experience in pharmaceutical industry or equivalent· Technical knowledge of US regulations· Knowledge of ICH and GXP Guidelines· Ability to coordinate regulatory submissions with minimal supervision· Proficient computer and word processing skills· Strong attention to detail and organization skills Strong written communication skills and interpersonal skills Works effectively in a team environment Flexible and adaptable in changing environments Bachelors degree Preferred Qualifications· Technical knowledge of EU regulations· Direct experience with preparing documents for eCTD submissions· Proven ability to identify documents that are not eCTD compliant   MRINetwork, one of the world's largest search and recruitment organizations, has over 1,000 offices in more than 35 countries. Each office is a single point of contact that allows candidates to access high-quality positions virtually anywhere in the world. MRINetwork recruiters are industry specialists who typically have real-world experience in the industries they serve. LOCATION: San Diego, CA 92101 JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee SALARY: 95,000.00 - 115,000.00 USD /yeardepending on experience JOB REFCODE: TMC082608CA San Diego COMPANY: MRINetwork EMAIL: Apply by Email