Independently compile high quality regulatory dossiers and technical documents, including information gathering, technical compilation, review and publishing activities to ensure that all required (non-EU, non-NAFTA, ROW Vaccine) submissions are prepared and submitted within established time lines. Provide guidance to management, project teams and other functional areas with respect to country specific/international licensing requirements, options and time lines. Post approval responsibilities include support for and completion of change control activities, renewal applications, variations and general RA support to OPU's, excluding NAFTA and EU.
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:
Provide high quality, professional, verbal and written regulatory input to local or international product (development) teams and other BIV departments as appropriate.
Participate on various global project teams as core or sub-team member.
Work with stakeholders/functional units to complete or acquire required documentation for submissions which may include outlines of production, manufacturing, quality testing documentation, labeling, R&D reports, import documents or international submissions. Carefully consider and align stakeholders on the degree of manufacturing disclosure.
Communicate and give guidance to other departments regarding country specific regulatory requirements, required report formats and time line expectations.
Independently complete/compile submissions including drafting cover letters, application forms, and associated documents.
Provide final submissions to designated BIV operating units as requested.
Provide technical and strategic regulatory information and advice to management and BI operative units in response to regulatory authority questions.
Support company licenses/species strategies and communicate directly with OPUs, project teams and attend agency meetings as appropriate.
Ability to effectively communicate and simplify technical information appropriately for BI operative units.
Participate in drafting and review of department working instructions and SOPs, including process optimization. Perform special projects as assigned.
General regulatory activities, including proficiency and utilization of company databases and tracking systems. Maintain knowledge of current regulations for non NAFTA and Non EU international regulatory environment and understanding of vaccine development, manufacturing and testing requirements.
Provide regulatory project guidance to Specialists and Senior Specialists.
Advanced degree (eg. MS or PhD) in Sciences with a minimum of five (5) years' experience within a regulatory affairs environment, or BS with minimum of eight ( )8 years regulatory experience.
Regulatory and international licensing experience an advantage with direct licensing experience in China, Brazil, India and/or Russia preferred.
Established track record of working within regulated pharmaceutical industry environments and within complex international team environments desired.
Detailed understanding of US vaccine development production and testing required.
International experience required.
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.