Sr. Regulatory Affairs Assoc / Manager

Sr. Regulatory Affairs Assoc / Manager 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 position is responsible for the routine regulatory support of assigned projects. This individual is expected to provide guidance within Regulatory Affairs and all other data generating departments to support timely filings and maintenance of assigned inflammation programs.Duties and Responsibilities:Responsibilities include project support for assigned inflammation programs:Represent Regulatory Affairs at various 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, Assist with managing submission activities (IND/CTA, trial maintenance, NDA/BLA) and assist with health authority interactions (meeting requests and briefing documents), Assist with preparing orphan drug designation and fast track development requests,as well as ensuring 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 2-3 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 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 project management, problem-solving, interpersonal and communication skills (both written and oral).Click here to immediately applyWant to learn more about us? Years of Experience Required: At Least 1 YearExpected 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: 14467.26412.5365BR Company: Millennium Pharmaceuticals, Inc. Status: Full Time, Employee Job Category: Biotech/R&D/Science