Manager Of Regulatory Affairs Jobs in North Carolina

Job Title: Regulatory Affairs Manager Company: BASF, The Chemical Company Location: Asheville, NC Description: BASF, The Chemical Company, is a Fortune 100 chemical company dedicated to making products that make our customers' products better. At BASF, we make careers better, too. Throughout the 20th century, BASF has played a leading role in agriculture and nutrition. BASF Plant Science (BPS) was founded in 1998 and is represented at seven sites in four countries. With this international network of expertise, BPS is especially well equipped to be a leader in plant biotechnology. We develop sustainable solutions for superior agricultural productivity, better and healthier nutrition and renewable resources. Leadership, creativity, teamwork and passion combined with our unique plant biotechnology expertise are the foundation for our success. BASF Plant Science (BPS) is seeking to appoint an innovative and experienced Regulatory Affairs Manager based in Research Triangle Park, NC, U.S.A. The Manager will be responsible for Regulatory Affairs leadership of the BPS biotechnology herbicide tolerant (HT) crop products, and will report to the Director, Global Regulatory based in the USA. He/she will provide a strategic overview for developing and implementing regulatory project plans for BPS biotechnology HT crop products globally, to achieve timely country regulatory approvals consistent with the overall objectives of BPS's HT crop biotechnology business. The Manager will have direct responsibilities for regulatory approvals of BPS's HT crop products in the U.S.A., and will have a leadership role in implementing the overall global regulatory project plan for BPS HT crop products by coordinating regulatory work packages with BASF Regulatory Affairs Managers in other countries for production and/or HT crop imports. Specific responsibilities include: developing and implementing regulatory project plans for BPS's biotechnology HT crop products, that include details of safety assessment studies, timelines and resource requirements, and the Manager will also be responsible for managing the regulatory budget of the BPS HT crop projects. The Regulatory Affairs Manager will ensure that the global regulatory project plans for the BPS HT crop products meets the regulatory requirements of all countries where regulatory approvals will be obtained. He/she will work collaboratively with the BPS Regulatory Science and Development teams, responsible for safety study execution and agronomic/ecological evaluations, respectively, to ensure agreement on study design, details, quality expectations and delivery timelines. The Regulatory Affairs Manager will be responsible for ensuring the best quality regulatory data development, writing and managing high quality regulatory submissions for the U.S. as well as working closely with BASF Regulatory Affairs Managers in other countries to produce similar high quality regulatory submissions for production and/or import of BPS HT crop products in these countries. He/she will also serve as an expert resource on all regulatory aspects of the BPS HT crop products, and steward all regulatory submissions to final approvals, by early issue identification, responsiveness to questions and requests from Regulatory Authorities, submission management and resolution of regulatory challenges. The position offers both an exciting opening in an international environment and an interesting professional and personal development opportunity within the BASF global network. Qualifications Required: • Ph.D. degree in a scientific discipline, such as molecular biology, plant biology, horticulture or agronomy with 8 years experience, or a M.S. with 10 years experience or a B.S. degree with 13 years experience in biological, biotechnological or another agricultural related science. Experience in alternative industries might include the seed business, food science or nutrition, or protein chemistry. BASF recognizes Institutions of Higher Education which are accredited by the Council for Higher Education Accreditation or equivalent. • At least three years of professional experience in Plant Biotechnology Regulatory Compliance, Regulatory Science or Regulatory Affairs. Must be knowledgeable and have working experience with the U.S. regulations and policies covering the use of biotechnology crop plants. • Abilty to effectively interact with the U.S. Regulatory Authorities and present eloquent arguments in the critical area of plant biotechnology. • Familiarity with regulations in other countries. • Strong intercultural orientation and interest in a multicultural environment. • The ability to work in or with a multinational team is of substantial importance for this position. • Developed team leadership and project management abilities. • Demonstrated creativity and motivated team player. • Demonstrated cross-functional communication, interpersonal, oral and written communication skills. • Ability to focus on multiple issues at one time, and must have the ability to meet goals and to attain the desired results, often under time pressure and in a fast changing environment. BASF recognizes Institutions of Higher Education that are accredited by the Council for Higher Education Accreditation or equivalent. This position is within a job family and will be filled at a level applicable to the incumbent's qualifications. To Apply: Please note that we accept online applications only, through our website at http://www.basf.com/careers. Please click on "Search job openings," and enter 1000077 into the keyword search box. We offer compensation and benefits that reflect our leadership position. For more information about careers at BASF, The Chemical Company, or to view all of our current openings, visit our website at http://www.basf.com/careers. No search firms. An Equal Opportunity Employer.

Job Title: Manager of Regulatory Affairs (EPA) Company: FPC of Greensboro Location: Charlotte, NC Description: A Major Manufacturing team is searching for a Regulatory Affairs Leader to provide leadership and direction to ensure compliance to GMP, FDA regulations. The incumbent will develop quality plans and controls around new product development, assist with continuous improvement, and insure product safety requirements are met.  Excellent benefits and relocation package.  Must have Bachelors degree in a major scientific discipline (preferably Chemistry or Microbiology) with 8 plus years QA/RA experience, in medical devices with greater than 3 yrs experience as manager of QA/RA activities.  Demonstrated knowledge of EPA, TSCA, FIFRA, PMN process CONEG, REACh, Prop 65, EU Biocide Directive, and Chemicals Management regulations for pesticides and biocide product formats.  Possess a strong working knowledge of FDA’s Quality System Regulation (QSR) and practical application through design control, SOP’s, verification, and validation testing, with experience in creating quality systems.  Understanding of process, manufacturing, engineering, market research, marketing, and legal matters obtained through experience and/or advanced education.  Up to 20% travel required. For SCM, Six Sigma, Lean Management, Quality and Engineering or Medical Device / Biotech opportunities; please visit our website at http://www.fpcgboro.com .

Job Title: Project Manager, Regulatory Affairs, Global Laser Enrichment Company: General Electric Company Location: Wilmington, NC Description: The Project Manager, Regulatory Affairs, Global Laser Enrichment will lead and coordinate the licensing strategy, generation of licensing documentation, and interactions with the U.S. NRC for licensing of a new enrichment facility and other assigned FGP projects, working with Project Managers, Engineering, Legal, EHS Licensing, Washington Regulatory Affairs Director, and other involved internal and external parties. Responsible for implementation of management systems and report to corporate and regulatory authorities Accountable for quality and timeliness of all licensing deliverables to NRC and other Responsible for defining, scheduling, and resource planning as well as work direction of other Licensing Engineers for all licensing submittals and related activities Responsible for coordinating with FGP Project Managers and Engineering for defining, scheduling, and resource planning of engineering needed for licensing submittals and related activities Stay abreast of regulatory trends and changes that may affect licensing and incorporate these changes into the licensing strategy Work with the Washington Regulatory Affairs Director, Regulatory Affairs' Project Managers, and EHS Licensing to plan, coordinate and provide GE representation as needed at NRC and other industry meetings dealing with licensing for assigned projects Provide representation and lead GE participation in licensing-related industry task forces that affect licensing Project Management of contracted work force providing licensing engineering supporting licensing including arranging for contracting of resources and budget control Responsible for implementation of management systems and reporting to corporate and regulatory authorities Qualifications/Requirements Bachelors degree in Science or Engineering discipline Minimum 5 years experience implementing NRC regulated programs such as Nuclear Safety, Radiation Protection, Material Control and Accountability and Transportation Licensing Currently hold or within the last 2 years hold a security clearance (NRC or DOE Q) GE will only employ those who are legally authorized to work. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.

Job Title: Project Manager, Regulatory Affairs, Global Laser Enrichment Company: GE Energy Location: Wilmington, NC Description: Job details Job Number 1154936 Business GE Energy Business Segment Energy - Power & Water About Us GE is working for a better future. Are you ready? For more than 125 years, GE has been respected for its performance and innovative spirit. GE people worldwide are dedicated to turning imaginative ideas into leading products and services that help solve some of the world's toughest problems. Looking for a challenge where your experience is valued? Come see what you can achieve as a leader with GE Energy! Posted Position Title Project Manager, Regulatory Affairs, Global Laser Enrichment Career Level Experienced Function Engineering/Technology Function Segment Product Design and Development Location United States U.S. State or China Province North Carolina City Wilmington Postal Code 28402-2819 Relocation Expenses Full Expenses Role Summary/Purpose The Project Manager, Regulatory Affairs, Global Laser Enrichment will lead and coordinate the licensing strategy, generation of licensing documentation, and interactions with the U.S. NRC for licensing of a new enrichment facility and other assigned FGP projects, working with Project Managers, Engineering, Legal, EHS Licensing, Washington Regulatory Affairs Director, and other involved internal and external parties. Essential Responsibilities Responsible for implementation of management systems and report to corporate and regulatory authorities Accountable for quality and timeliness of all licensing deliverables to NRC and other Responsible for defining, scheduling, and resource planning as well as work direction of other Licensing Engineers for all licensing submittals and related activities Responsible for coordinating with FGP Project Managers and Engineering for defining, scheduling, and resource planning of engineering needed for licensing submittals and related activities Stay abreast of regulatory trends and changes that may affect licensing and incorporate these changes into the licensing strategy Work with the Washington Regulatory Affairs Director, Regulatory Affairs' Project Managers, and EHS Licensing to plan, coordinate and provide GE representation as needed at NRC and other industry meetings dealing with licensing for assigned projects Provide representation and lead GE participation in licensing-related industry task forces that affect licensing Project Management of contracted work force providing licensing engineering supporting licensing including arranging for contracting of resources and budget control Responsible for implementation of management systems and reporting to corporate and regulatory authorities Qualifications/Requirements Bachelors degree in Science or Engineering discipline Minimum 5 years experience implementing NRC regulated programs such as Nuclear Safety, Radiation Protection, Material Control and Accountability and Transportation Licensing Currently hold or within the last 2 years hold a security clearance (NRC or DOE Q) Additional Eligibility Qualifications GE will only employ those who are legally authorized to work. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen. Desired Characteristics NRC Licensing process and technical regulatory knowledge in one or more areas such as fuel facility licensing, new plants, fuel, operating plants Existing NRC or DOE “Q” clearance Prior experience in working / communicating with Nuclear Regulatory Commission (NRC) personnel Experience working with industry groups, such as NEI and Owners Groups, on nuclear licensing matters Inclusive - Ability to communicate well with all levels of the organization; Open communication style and the ability to develop team relationships; Excellent interpersonal and influencing skills Clear Thinker - Ability to make decisions with speed and accuracy, based on the best available information; Commitment to continually strive to increase knowledge with up to date information External Focus - Ability to create a positive representation of GE externally to customers and regulators Autonomy - Demonstrated ability to be a self-starter; ability to work independently with little to no oversight; ability to deal effectively with complex, ambiguous and contradictory alternatives Why join one great company when you can join many? We are more than 300,000 people with jobs that range from biochemist to finance specialist to wind energy engineer. We’re passionate about making life better with new ideas and technologies. We’re diverse, supporting our communities in more than 140 countries. Experience personal growth and competency development as part of the GE team. GE Energy is leading the field in the development, implementation and improvement of the products and technologies that harness our resources such as wind, oil, gas and water. GE Energy is one of the world's leading suppliers of power generation and energy delivery technologies in all areas of the energy industry including coal, oil, natural gas and nuclear energy as well as with renewable resources such as water, wind, solar and alternative fuels.www.ge-energy.com Wilmington is beautiful city rich with art, culture, beaches, natural beauty and history. National publications have listed Wilmington as one of the 100 Best Small Art Towns in America as well as one of America’s 100 Best Retirement Towns. Come see why we love Wilmington! Index Monitor

Job Title: Regional Director of Regulatory Affairs Company: MRINetwork Location: Raleigh, NC Description: Regional Director of Regulatory AffairsThe Company:Dynamic, growth oriented company is a leading global provider of laboratory instruments and solutions in biopharmaceuticals, forensics and clinical diagnostics. Company was founded in 1980 and is the market leader in automated laboratory storage and logistics systems. The Opportunity:The Regional Director of Regulatory Affairs will ensure that all products are manufactured in compliance to applicable standards and regulations. The selected individual will also serve as the company representative interface to competent authorities and will also be responsible for surveillance of regulatory issues. The Regional Director of Regulatory Affairs reports locally to the President and General Manager and globally to The Sr. VP of Quality and Regulatory. Essential Responsibilities:• Consults with all departments regarding regulatory affair issues and organizes quarterly complaint meetings. • Manage regulatory affairs specialist and perform internal trainings on regulations. • Follow all safety procedures and State/Federal OSHA Regulations and report and concerns.• Report all applicable adverse events to authorities.• Define product classifications for defined markets and review advertising, promotional and labeling materials.• Create and implement global procedures, lead and support regulatory affairs projects. • Review customer contracts and technical change requests. • Oversee product declarations, certificates and related documents. • Perform inter-company audits, complaint reporting and evaluate applicable complaints for reportability. • Prepare product submissions and coordinate recalls and field corrections. Essential Qualifications: • 5+ years of experience working in a similar capacity with well-documented, successful work history. • Previous position working for the FDA (Food & Drug Administration) or working within the FDA highly preferred. • Must have FDA, Quality Assurance, Process Management, Regulatory Affairs, IVDD, MDD and GMP Experience. • Degree in Microbiology, Biochemistry or Medical Science is necessary plus additional training/education in Quality Assurance, Process Management and Regulatory Affairs. PhD is preferred. • Strong ability to recognize and manage potential problem areas and resolve them efficiently and with integrity.• Excellent organizational skills, excellent inter-personal skills and a very high level of self motivation. Must be able to work independently. • Excellent communication skills, written and oral. Must be able to speak English fluently and fluent German would be a great plus. • Strong ability to work with existing teams and build/support strong teams.• Ability to travel nationally and internationally up to 40% of the time.• Ability to reside and work in the Raleigh-Durham area of North Carolina. Compensation:Excellent company in a growth mode offering a base of $100,000 + plus bonus potential, full benefits, excellent working conditions. Key Words:Director of Regulatory Affairs, Regulatory Affairs Director, FDA, IVDD, MDD, GMP, clinical diagnostics, liquid handling, automated laboratory equipment, diagnostic laboratories.

Job Title: Director of Regulatory Affairs - Medical Device BHJOB3594_219 Company: Location: Raleigh, NC Description: The Wellington Group is seeking an experienced regulatory affairs professional for an exciting new medical device / combination therapy position. Excellent opportunity to help bring new medical devices to the global market! The Director of Regulatory Affairs is a key role in the development, research and commercialization of new products and the management of regulatory and quality disciplines for the organization. The Director will ensure that the company complies with applicable global regulatory requirements and standards for the development, pre-clinical and clinical evaluation, manufacturing, and marketing of its products. Responsibilities include: ? Lead a team of regulatory professionals to define and implement the regulatory strategy ? Lead the preparation, submission, and timely approval of regulatory applications ? Lead the interaction and negotiations with regulatory agencies ? Maintain regulatory procedures and documents to maintain approvals and certification for development, manufacturing, and marketing of products ? Inform senior management of regulatory requirements and status of products and significant regulatory issues/trends The qualified candidate will have: ? 10+ years of Regulatory Affairs experience with at least 4 years of medical devices and 4 years in senior manager ? 4-year degree required, graduated degree preferred ? Experience in providing regulatory direction to development, pre-clinical and clinical evaluation, manufacturing, and marketing of combination products ? Experience in preparing and obtaining approval of device/drug combination products ? FDA/ISO/CE submissions and follow-up maintenance activities for approvals and certifications ? Significant experience planning for and management of regulatory compliance audits Industry: Medical Devices, Biologics, Pharmaceutical Location: Either RTP, NC or Cambridge, MA Job Code: BHJOB3594_219 Recruiter: Lisa Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance. Don?t wait, apply with The Wellington Group today! (all information will be held in the strictest of confidence) The Wellington Group ( http://www.twgrecruiters.com ) Register to View