Regulatory Affairs Manager, Vaccines

Regulatory Affairs Manager / Senior Regulatory Affairs ManagerExciting opportunity for to work with an established multinational company in their vaccines division! This is a chance to be part of having a lasting impact on humanity as this division is working on vaccines in some critical areas such as pandemic flu, seasonal flu as well as others. They are seeking an individual who have a strong scientific and regulatory skills who have some experience with vaccines. The responsibilities are as follows: Develop and execute regulatory plans for complex US Vaccine projects including new product development and maintenance of licenses/authorizations for existing marketing authorizations Provide regulatory input on non clinical, clinical and CMC development issues Represent or lead the RA function on assigned cross-functional project teams Monitor applicable regulatory requirements; assure compliance with Baxter and external standards Establish appropriate communication within RA and other functions primarily at project level Perform gap analysis and propose solutions Develop and document sound regulatory decisions and justifications Ensure project teams and business objectives and deliverables are aligned with regulatory strategy May provide direct supervision of individuals May review promotional material or SOP’s for compliance with local and global regulations The idea candidate will have the following qualifications: Strong basis of Regulatory knowledge, previous experience in vaccine development will be an advantage Strong Scientific Knowledge Direct Experience with FDA and other Health Authorities Experience with BLA/NDA and supplement submissions Ability to manage complex projects and timelines in a matrix team environment Experience working on global project teams Strong verbal and written communication and presentation skills Demonstrated interpersonal skills including strong negotiation skills Ability to independently identify compliance risks and escalate when necessary Ability to lead and coach others Master's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA, including managing people or projects. Higher degree/PhD will be an advantageAll are encouraged to apply. For additional regulatory affairs openings please visit our website www.executivesg.com     MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: MD 20705 JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee COMPANY: MRINetwork