Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in support of maintenance and compliance requirements as well as development projects. Provide super-user technical support to team members and cross-functional stakeholders for various internal systems and software programs, as well as specialized regulatory software. Provide support to the Regulatory Team as needed in pursuit of Company goals and objectives.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees
Duties & Responsibilities:
Acquire and review required scientific and technical documentation for all types of regulatory submissions including, but not limited to, FDA annual reports, technical sections and related amendments and supplements. Communicates and provides guidance to other departments and/or stakeholders regarding documentation format and time-line requirements.
Responsible for tracking submission due dates, agency response due dates, regulatory chronology, regulatory communications and other metrics as needed.
Provides "super-user" system expertise for electronic submissions; interfaces directly with internal technical support, as well as external regulatory agency technical support to ensure regulatory submissions are completed in accordance with project time-line objectives.
Support Regulatory Affairs team in various meetings, project team activities, or special projects as assigned. Provide relevant regulatory guidance to internal leaders and timely interactions with external regulatory agencies.
Responsible for writing and implementing best practices and standard operating procedures regarding regulatory submissions/requirements as needed and in support of the team. Maintains advanced and current knowledge of relevant regulations, policies and guidelines. Provides guidance within the regulatory department and/or cross-functionally relative to regulatory compliance of BI products and processes.
Bachelor degree in science, political science, business or related field with a minimum of 3 years regulatory affairs experience in a GxP environment.
Preferably experience would include at least one 1 year of leading or co-leading projects from end to end.
In lieu of degree, may have a minimum of 8 years regulatory affairs experience to include demonstrated ability in creation of regulatory documents, electronic submissions, project development, regulatory software and interaction with regulatory agencies in a GxP environment. Ability to communicate effectively, both orally and in writing.
Flexibility and ability to make intuitive and independent judgments.
Ability to organize well and co-ordinate assignments. Excellent attention to detail and proof-reading skills.
Organized, confident, accurate, working to deadlines and computer skills.
Must be proficient in business software programs such as Micro Soft Office Suite and Adobe, as well as provide super-user knowledge for specific business programs such as regulatory submissions, repository, tracking, and reporting systems. Must possess ability to provide electronic submission software expertise.
Must have excellent written and verbal communication skills, maintaining professional interactions with management, internal stakeholders, and regulatory agencies.
Minimal travel is anticipated.
Must be legally authorized to work in the United States without restriction
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Boehringer Ingelheim Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.