The Regulatory Affairs Labeling Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US product labeling. The position will also offer the opportunity to complete rotations in areas within and beyond Regulatory Affairs.
The Fellow, under supervision, will be exposed to projects involving both US marketed products and investigational projects. Under supervision, the Fellow will:
Provide analysis, advice and guidance on US regulatory labeling strategies.
Research information on regulatory labeling standards and departmental policies.
The Fellow will develop basic regulatory labeling expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory labeling advocate to achieve common goals for assigned projects, with supervision.
With supervision, the RA Labeling Fellow will:
Chair meetings of the Product Label Review Teams (PLRT) for each assigned marketed product and provide functional support for discussions such as the Annual Labeling Review, Company Core Data Sheet (CCDS) Updates, and other ad hoc issues as they occur (e.g. FDA requests for labeling changes). As part of PLRT, draft/revise product labeling and compile supportive documentation. Ensure that each marketed product’s labeling is in line with the company's CCDS in a manner consistent with the local health authority's regulations and guidelines. Assure timely availability of preparatory documentation before the meetings, identification of issues for discussion, and prepare meeting minutes following the meeting, as well as follow up on outstanding issues for complete resolution.
Bring PLRT proposals to Product Labeling Committee (PLC) for discussion, review, and approval as required.
Coordinate preparation of regulatory labeling documents needed for regulatory submissions with contributing functions in other departments such as RA Product Labeling Operations, RA Operations, and RA Product Groups. Review Labeling Content deliverables for submissions for completeness, consistency and accuracy of proposed changes and supportive documentation, making recommendations or suggestions back to the PLRTs or RA Product Managers as appropriate. Review labeling section of NDA Annual Reports, PADERs, PBRERs.
Assist with FDA interactions, such as labeling negotiations, on assigned projects/products.
Interact with Global Labeling (GL) before major US labeling changes to ensure consistency with company core labeling, or the need for a revision to the core labeling. From a labeling perspective, advice on suitability of CCDS proposals for implementation in the US, provide impact assessment on US labeling, and function as a liaison to the PLRT to facilitate US-specific labeling feedback and needs into Global RA sub-teams.
Demonstrate proficient and consistently evolving labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting regulations and guidances, particularly in the area of product labeling.
Review regulatory developments with RA Product Labeling Groups and keep BI abreast of changes in the US regulatory environment impacting product labeling.
Maintain excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions.
Support late-stage development labeling for NCEs/NBEs and labeling supplements initiated by BI, in conjunction with RA Product Labeling Management and the assigned RA Product Manager in the RA Product Groups.
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.
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.
Excellent proofreading and editing skills.
Ability to work in a team-based environment with personnel within RA, as well as other functions.
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.