Manager / Senior Manager Regulatory Affairs

Our client company is a growing biopharmaceutical company developing & commercializing a broad range of therapeutics for critical care and hospital care. Assume a key role leading the preparation and review of regulatory submissions, at a growing company with excellent career growth prospects.CONTRIBUTIONS:· Provide regulatory support to project teams and manage regulatory documentation and information.  Â· Management of IND and CTA submissions in the US and EU.· Performing regulatory activities in the preparation of NDAs and MAAs.· Provide regulatory research & regulatory assistance to project teams, in support of attaining market authorization of pharmaceutical products to commercialization. Review critical documents (labeling, protocols, ICFs) for submission to health authorities. Communicate regulatory requirements and ensure all development activities are in compliance with applicable regulations and guidelines. Represent Regulatory Affairs at various project team & working group meetings. Contribute to the development of regulatory strategy plans. Manage submission activities (IND/CTA, trial maintenance, NDA/MAA). Interact with the FDA and health authorities as needed (meeting requests and briefing documents). Ensure the quality and content of all regulatory submissions. Provide guidance and direction to other regulatory employees. CAPABILITIES: Bachelor degree in a scientific discipline strongly preferred. Minimum of 5-10 years regulatory experience in the pharmaceutical industry or equivalent. Solid technical knowledge of US, EU, ICH regulations and GXP guidelines. Ability to coordinate regulatory submissions with minimal guidance or direction.  Direct experience preparing documents for eCTD submissions. Proven ability to identify documents that are not eCTD compliant and actions needed to make them fully compliant. Solid track record of hands-on experience. Proficient computer and word processing skills, strong attention to detail, good organization skills. Strong written communication skills and interpersonal communication skills. Works effectively in a team environment. Flexible and adaptable and comfortable working in a changing environment. Able to travel periodically ~10% or less in the US and Europe. If this opportunity does not meet your needs but you know someone that is qualified, please refer this opportunity to them. 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 COMPANY: MRINetwork CONTACT NAME: Fred Gordon EMAIL: Apply by Email