Regulatory Affairs Manager

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. Manager – Global RA Pharmaceuticals The candidate will be responsible for all technical aspects of global regulatory submissions for assigned drug products, including development of regulatory strategies, and defining submission requirements. Responsibilities will range from working with development teams on new ANDA and 505(b)(2) submissions through post approval maintenance, with an emphasis on regulatory compliance and life cycle management. Candidate must demonstrate the ability to understand regulations and FDA guidances and have the ability to interpret and develop regulatory strategies that provide optimum regulatory relief for the manufacturing sites while maintaining the utmost in regulatory compliance. Candidate will have global responsibility for all technical aspects of assigned drug products while working with the regional representatives to develop global submission strategies and requirements and resolve any regulatory issues that may arise. Individual will work closely with multi-functional teams and interact with scientists, quality, manufacturing and technical departments to assure that global regulatory submission needs are met in a timely and efficient manner. Strategic thinking and risk assessment/contingency planning are essential along with the ability to anticipate regulatory responses through scenario planning and communicate areas of risk to project teams and regulatory management while also advising on course of action. Candidate will have primary responsibility as FDA liaison for all assigned products and will be expected to negotiate with regulatory agencies and make recommendations to the project teams to expedite submissions and product commercialization timelines and ensure positive outcomes for submissions. This position will also be responsible for reviewing change controls, managing submission requirements and preparing supplements for their responsible products. QUALIFICATIONS: Minimum of Bachelor's degree in relevant scientific discipline is required. Minimum 4-6 years experience in US Regulatory Affairs submissions for generic and/or proprietary drugs with 7 –9 years experience in the Pharmaceutical Industry. Experience and/or basic knowledge of clinical trial requirements are a plus. General knowledge of ICH regulations and CTD submission experience is required and will ensure ability to perform the responsibilities of a Global Product Owner. Candidate must demonstrate ability to interpret regulations, guidelines and all technical product information to assure regulatory requirements are being met for continued market supply of drugs. Excellent interpersonal and collaboration skills, ability to identify and proactively resolve problems are required. Candidate must be self-motivated and have excellent written and verbal communication skills. Strong commitment to teamwork, quality and customer satisfaction are essential. As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.