Manager, Regulatory Affairs

Job Description:Company Information:Breakthrough Careers!A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.Position Summary:This Manager position serves as a liaison between the company and regulatory agencies for all assigned projects and is responsible for their day to day regulatory support. This individual is expected to provide guidance within Regulatory Affairs and all other data generating departments to ensure timely filing and approval/maintenance of assigned inflammation programs.Duties and Responsibilities:Responsibilities include project support and planning for assigned inflammation programs:Represent Regulatory Affairs at various project team and working group meetings, Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines, Contribute to the development of regulatory strategy plans, Manage submission activities (IND/CTA, trial maintenance, NDA/BLA) and health authority interactions (meeting requests and briefing documents), Prepare orphan drug designation and fast track development requests,ensure the quality and content of all submissions to health authorities.Qualifications:Basic qualifications:Position requires a minimum 4-year degree in a scientific or technical discipline. A minimum of 4-6 years of regulatory experience in the biotech, pharmaceutical or medical device industry. Previous experience in supporting submission teams for marketing application and/or clinical trial applications is also required.Preferred qualifications:Must demonstrate a solid working knowledge of the drug development process and knowledge of FDA regulatory requirements. Experience in EU, Canada, ROW and Post-marketing would be helpful. Candidates must be able to demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).Click here to immediately applyWant to learn more about us? Years of Experience Required: 3-5 YearsExpected Travel Time: None Searchable Keywords: SAS / gj-moExpected Travel Time: None Company: Millennium Pharmaceuticals, Inc. Contact: Recruiter Email: Apply by Email Address: 02454 Reference Code: 14467.26412.5348BR Company: Millennium Pharmaceuticals, Inc. Status: Full Time, Employee Job Category: Biotech/R&D/Science