Boehringer Ingelheim Specialist, International Reg Affairs - 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.
To independently initiate information gathering, compilation and publishing activities to ensure that all required submissions are prepared and submitted within established timelines. Proactively interact with senior colleagues to provide 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:
Acquire required documentation for any type of submission; communicates and give guidance to other departments regarding format and timeline expectations (create documents and prepare registration filing).
Compile routine submissions which may include compilation of outlines of production, labeling, facility documents and export certificates.
Provide review notifications for facility documents and production outlines to annual reviewing contributors; compile and review materials for cross-functional Management review/approval.
Participate in drafting and review of department working instructions and SOPs for activities relevant to this position and performs special projects as assigned.
Organizes and provides training on the use and function of regulatory systems and requirements (e.g. CPD-2, facility documents, production outlines, etc.)
Bachelor degree in science with a minimum of 2 years previous business or regulatory affairs experience.
Basic knowledge of US and/or international regulatory processes.
Ability to communicate effectively, both orally and in writing
Flexibility and ability to make intuitive judgments
Ability to organize well and co-ordinate assignments
Good attention to detail and proof-reading skills
Organized, confident, accurate, working to deadlines and computer skills
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., 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, International Reg Affairs - Contract
Location: Americas-US-MO-Saint Joseph
Requisition ID: 1815983