The Regulatory Policy and Intelligence Fellowship is designed to provide pharmacists with exposure to regulatory intelligence and policy activity within the pharmaceutical industry. The position will also offer the opportunity to complete rotations in areas within and beyond Regulatory Affairs.
The Fellow will be exposed to projects involving both US marketed products and investigational projects. Under supervision, the Fellow will:
Develop, compile, and integrate regulatory intelligence from health authorities, professional groups, publicly available information and BI.
Appropriately communicate regulatory intelligence within the organization.
Provide analysis, advice, and guidance on US regulatory strategies to promote expedited product development and approval.
Research information on regulatory policies and departmental policies within and external to RA.
Research and implement processes to improve regulatory intelligence and collaboration.
Develop expertise on projects from the regulatory intelligence and policy perspective.
Collaborate with BI Government Affairs to ensure knowledge sharing of overlapping intelligence topics.
The Fellow will develop basic regulatory policy and intelligence knowledge across the spectrum of BI assets and marketed products. Interact effectively within Regulatory Affairs and across functions, as a US regulatory advocate to achieve common goals for assigned projects, with supervision.
With supervision, the Regulatory Policy and Intelligence Fellow will:
Proactively review and evaluate relevant US regulations and guidelines, as well as evolving regulatory trends and developments for their impact on drug and device development activities and on existing development strategies.
Lead requests for global country-level regulatory information from various partners.
Handle the development of custom reports to support regulatory compliance and advise strategy.
Collaborate with partners to support any compliance and process initiatives.
Own the review and refinement of regulatory FDA guidance and recommendations by developing written comments reflecting BI’s priorities for submission to health authorities.
Supervise the evaluation of new regulatory intelligence data sources and service providers.
Serve as Regulatory intelligence lead on highly sophisticated cross-functional teams.
Provide regular communications and briefings to global and regional policy management on relevant global regulatory policy issues.
Participate in internal product team meetings to provide regulatory policy context for business decisions.
Provide strategic regulatory advice to RA colleagues on drug development and device projects, registration, and marketed products in preparation for HA meetings.
Develop training materials and participate as a facility member on new and emerging regulatory requirements for RA colleagues and other line functions.
Analyze impact of important emerging regulatory policies and new requirements on projects and business.
Prepare and coordinate internal customer feedback on proposed laws, regulations and guidances, to ensure consideration of BI’s positions by trade organizations.
When appropriate, collaborate with Government Affairs to shape emerging legislative proposals.
Develop targeted and appropriate automation of regulatory information.
Basic knowledge of pharmacy gained through Doctor of Pharmacy program
Fellow should have basic understanding of:
Food, Drug and Cosmetic Act.
21 CFR regulations relevant to drug/biologic development and registration.
Other relevant US laws, regulations and guidance documents.
Medical, pharmaceutical and scientific knowledge and understanding in the assigned therapeutic area.
Minimum qualifications, education, experience:
Doctor of Pharmacy degree
Critical thinker with ability to self-direct workload, including reprioritizing and delivery under tight timelines.
Ability to analyze and interpret scientific data and regulatory guidelines?
Strong interpersonal skills, agility and willingness to adapt to a changing environment
Problem solving skills
Excellent oral and written communications skills with the ability to provide key messages in a concise manner.
Excellent meeting preparation and presentation skills.
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health 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; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.
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)
Boehringer Ingelheim is focused on science that leads to more health for our patients and their families. The discovery and development of innovative medicines is fundamental to our continued growth and success. Our blueprint for innovation is tailored to accelerate the delivery of breakthrough medicines to the patients we serve by integrating research, pre-clinical and early clinical development, translational medicine, and external partnering functions. This fusion of expertise combined with a dynamic research approach and an increased emphasis on external collaborations means we can effectively incubate the most creative ideas and be among the pioneers in emerging fields of medicine.