Regulatory Affaird Associate Director

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.


Global Product Ownership of key products. The position has decision/commitment making authority over the divisional business or products it supports in interactions with FDA, company and customer affiliates and outside professional associations. This authority extends to division technical, business, and management functions. The position will lead regulatory activities for a specific business or product line as well as a wide range of other divisional drug business programs where the products are marketed.


Essential Duties and Responsibilities:
1) Lead domestic and global regulatory strategy development and implementation to achieve complete regulatory submissions and timely, cost effective regulatory approvals for assigned business or product lines.2) Collaborate within the department to identify and implement vision and long term planning strategies, assuring regulatory viability of strategic business initiatives and ongoing submission compliance of existing products.3) Plan/review and approve development of required documents from various departments for filing of all required information to FDA4) Analyze/anticipate the regulatory environment to identify appropriate divisional change that may impact customer, products and/or operations.5) Collaborate with other managers to establish and implement policies to assure ongoing compliance with regulatory requirements.6) Manage internal and external forces to analyze and resolve submission conflicts/issues/problems. Advise the management on issues of product/process quality.7) Oversee relations and associated company credibility with key FDA groups.8) Collaborate with international colleagues to develop effective global strategies for product development and regulatory submissions to assure effectiveness of global business initiatives9) Recruit and hire. Lead, train and develop reporting resources and contribute to an environment that fosters collaboration, trust, regulatory and scientific excellence, creativity, and pro-activeness.Qualifications
Qualifications:
1) Expert technical, regulatory, and problem solving skills including an understanding of drug regulatory requirements, their foundation and submission processes, as well as a demonstrated track record of effective regulatory management.2) Solid basis in scientific approach and an ability to deal with in-depth technical information from a variety of disciplines and foster a high degree of scientific credibility with regulatory agencies.3) Advanced interpersonal skills and a demonstrated ability to manage conflict situations.4) Excellent oral and written communication skills.5) Established credibility and reputation within the profession and with FDA.6) Management experience and a demonstrated record of responsible actions consistent with the values of the business.7) Experience in effective collaboration with international colleagues and ability to speak a foreign language desirable.8) Establish competency in the area of regulatory guidelines

Education and/or Experience:
Advanced degree or equivalent and at least 5 years of professional experience in technical and regulatory disciplines.Excellent organizational skills and comfortable with standard office computer software.

Minimum of 8 years experience in RA, including at least three years experience managing people.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
REQUIREMENTS
Please see Job Description