Boehringer Ingelheim Specialist, Regulatory Labeling- Contract in SAINT JOSEPH, Missouri
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
Coordinates the creation and review of labeling materials for BI domestic and export markets, including relevant distributors or contract manufacturers. Ensures compliance with US government agency labeling regulations. Prepares submissions to agencies, including collection of supporting documents and English translations as needed. Review and approval of labeling-related BI documentation such as but not limited to Outlines of Production, case labels, and international dossier submission texts.
Per line manager instruction, initiates information gathering, compilation, and submission activities to ensure that all required submissions are prepared and submitted within established timelines. Proactively interacts with senior colleagues for guidance with respect to timelines and technical activities.
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:
Understands the needs and produces labeling instructions for internal or external Graphics personnel.
Completion of new labeling for product launches and labeling revisions for product maintenance, efficiently and accurately.
Complete and maintain documentation associated with all job assignments. Follow-up with stakeholders to ensure progress within agreed-upon timelines. Input and maintenance of APHIS approval data and documents in Regulatory systems. Responsible for of internal RA labeling approvals, which is a critical function for use in Operations.
Manage workload, priority, and task assignments with moderate supervision.
Provide Regulatory labeling advice to internal and external stakeholders. Provide answers on specific requests, or direction to appropriate source for answers.
Assist with development and maintenance of USA labeling texts in accordance with applicable regulatory agency requirements, with line manager assistance and in collaboration with RA product managers.
Bachelor's Degree in science or business related field from an accredited institution required.
FDA and/or EPA regulatory experience- preferred
Proficient in standard office technology, including Word, Excel, and Adobe Acrobat.
Strong written and verbal communication skills.
Strong attention to detail
Must exhibit good judgment, and ability to problem-solve issues in daily work.
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 neighbourhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, 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.
Title: Specialist, Regulatory Labeling- Contract
Location: Americas-US-MO-Saint Joseph
Other Locations: Americas-US-GA-Duluth
Requisition ID: 1814726