The Regulatory Affairs Product Strategy Fellowship is designed to provide pharmacists with exposure to all areas within Regulatory Affairs strategy. 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:
Act as a company liaison with the US Food and Drug Administration.
Provide analysis, advice and guidance on US regulatory strategies.
Research information on regulatory standards and departmental policies.
Develop expertise on projects in the assigned therapeutic area from the global regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance, market access and commercial perspective.
The Fellow will develop basic regulatory strategy expertise/knowledge in one or more therapeutic areas. 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 Product Group Regulatory Affairs Fellow will:
As a regulatory professional with basic knowledge in one or more therapeutic areas, interact effectively at all levels of the organization (local and global), within Regulatory Affairs and across functions, as a US regulatory advocate to achieve common goals for assigned projects.
RA Subteams and Intra-RA Project Responsibilities:
Effectively contribute US operational and strategic perspectives to RA subteam to ensure GRL and the subteam accurately consider US regulatory requirements and challenges in the global context.
Present or support review of US-specific regulatory topics to Regulatory Expert Group (REG), as appropriate.
Ensure US RA contributions to all local and global project related documentation such as management summaries, TALC / HPSC / DC pre-reads, are clear, complete and accurate, taking on leadership of the information as appropriate.
Global Project Team Support:
In collaboration with the GRL and RA subteam, provide leadership in the development and implementation of US regulatory strategy within a global development context.
Assess US strategic options and provide US regulatory advice to support assigned global development projects and Product Maintenance Optimization strategies, seeking US project team/management alignment as appropriate.
Assess opportunities for expedited US regulatory pathways. Define US strategic considerations in the generation of a Global Regulatory Strategy Document.
In cooperation with US/Global Labeling, provide project-related US regulatory input into content of the draft CCDS.
Provide US guidance to global team on FDA submissions, meetings, and pediatric development requirements including preparation of documentation, as appropriate
US-Focused Project Team Support:
Provide US regulatory strategic input and advice to US cross-functional teams during development, registration, and marketing approval. Includes, for example, detailed assessment of potential labeling claims to support US commercial activities based on clinical trial design and results, if available, taking into account US regulatory labeling precedence and FDA comments/guidance.
Pre-evaluations and External Partnerships:
Provide broad and well-informed US regulatory leadership to internal and external pre-evaluations (e.g. Due Diligence) and contribute to assessment reports. For projects with a CRO or licensing partner, provide and implement US RA strategic and operational perspectives/tasks, as appropriate.
Health Authority Interactions/Submissions:
Responsible for all FDA interactions on assigned projects/products, including formal meetings, FDA review of registration packages, and labeling negotiations.
Establish and implement US regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RA Subteam.
Provide regulatory leadership to ensure alignment with global and US team/management, as appropriate, in preparing responses to FDA requests.
Lead FDA meetings for assigned projects
Disseminate FDA interactions within BI, as appropriate.
Manage all formal submissions and informal communications to FDA for assigned projects/products, including clinical trial and marketing authorization applications.
Other Regulatory Contributions:
Provide US strategic regulatory guidance and input to key internal development, registration and commercialization documents for assigned projects (e.g. development plans, protocols, clinical trial reports, pediatric development plans, core dossier elements, integrated brand plans, market access documents, with particular emphasis on the US contribution within the strategic country prioritizations (i.e., “hyperfocus”).
Provide US regulatory leadership in the preparation, content, and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products, with guidance from management, GRL, US Legal, and GPV, as appropriate.
As defined by respective BI processes, review and release, via cross-functional medical-legal-regulatory team, US core messages, as appropriate (e.g., press release, stand-by statements).
Proactively review and evaluate relevant US regulations and guidelines, as well as evolving regulatory trends and developments for their impact on drug development activities and on existing development strategies.
Share new/novel "on the job" US regulatory intelligence/experience with peers, as appropriate
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.