Manager, Regulatory Affairs

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

Position Summary:

The purpose of this position is to ensure marketing approval of new and modified drug products in the US and foreign countries. As part of the Regulatory Affairs Group, the candidate will be responsible for global regulatory tasks including but not limited to regulatory submissions and registrations, regulatory liaison with regulatory agencies and project team participation to interact with internal functional departments. The candidate will provide strategic input and guidance to project teams and act in a supervisory capacity for regulatory staff.

Responsibilities: Essential Duties

• Plan, develop, prepare, and review appropriate domestic and international regulatory submissions, such as NDAs, ANDAs and INDs.
• Regulatory liaison with regulatory agencies and primary regulatory contact for assigned projects.
• Supervise regulatory staff functions including development, training, performance reviews and setting objectives.
• Provide input for regulatory requirements and regulatory strategy in interdepartmental meetings on product development to ensure timely submission and approval.
• Review and make final determinations for regulatory assessments of proposed changes to existing products.
• Read, review, interpret and keep current with regulations and publications regarding drug products.
• Interact with B. Braun representatives of foreign countries and foreign health authorities regarding registration of products.
• Manage and prioritize development projects and day to day activities.
• Coordinate/Manage meetings and Agency interactions.

Expertise: Knowledge & Skills

• Excellent verbal and written communication skills
• Skilled in planning, organizing, coordinating projects and working independently
• Supervisory skills to oversee operations and develop career growth.
• Computer literate - Microsoft Office.
• Ability to prepare department reports and make management presentations

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• BS/BA in scientific discipline.
• Minimum five years experience in Regulatory Affairs.
• Prior experience in direct interaction with regulatory agencies such as managing meetings and agency interactions.
• Experience in the preparation of regulatory filings.
• Experience in making regulatory assessments of proposed changes and how they will impact current submissions.
• Able to analyze and develop strategies for regulatory submissions to ensure timely approval.
• Both problem solving, decision making and negotiating skills are required to the extent that regulatory submissions impact B. Braun's ability to sell products and impact the company's financial standing.
• Business travel requires valid driver's license, acceptable driving record and current passport.
• Previous supervisory experience.

Desired:

• Advanced degree.
• Regulatory Affairs certified.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.

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