The Regulatory Affairs (RA) Fellowship within the Chemistry, Manufacturing, and Controls (CMC) discipline is designed to provide pharmacists with a 2-year exposure to all aspects of the global regulatory CMC development of BI assets. The selected Fellow will also gain experience coordinating and executing regulatory activities required of an NDA Holder for compliance to FDA requirements for U.S. products in BIPI's commercial portfolio. These responsibilities include management of CMC and product labeling changes as well as the preparation and submission of supplemental applications and post-marketing reports per US regulations.
The Fellow will be exposed to projects involving both US marketed products and global investigational projects. Under supervision, the Fellow will:
Act as a company liaison with the US Food and Drug Administration.
Research information on global regulatory CMC standards and departmental policies.
Provide strategic regulatory input as it pertains to global CMC development projects and US Marketed Products
Author, review and update CMC documentation for both global development and US registered products.
The Fellow will develop basic regulatory expertise/knowledge in one or more therapeutic areas covering multiple dosage forms while interacting effectively within Regulatory Affairs and across CMC stakeholder functions, as a regulatory advocate to achieve common goals for assigned projects.
CMC Development: As a contributing member of the R&D Project Team and Regulatory Excellence Team, provide global CMC regulatory guidance on global development projects of increased complexity, define CMC regulatory submission strategies during development through the initial marketing applications. Contribute to the maintenance of BI's databases for CMC development requirements (e.g., Requirebase and CTA database).
CTA Submissions: Prepare the CMC Core Document List for Global CTAs. Develop risk analysis plans for potential deficiencies in CMC documentation prior to submission. Review, and approve regulatory documents for submission, construct IMPDs, and prepare and/or file CMC content in eCTD format for the US IND. Manage the responses to Health Authority questions with assistance from more experienced CMC RA colleagues, as needed. Prompt entries of the CMC questions from HAs into the RegCom database. Interact with stakeholders outside of CMC RA (e.g. QPs, CTSU, Analytical, etc) to ensure smooth IMP release process. Provide input as needed on CMC content in the DSURs.
CMC Lifecycle Management: Effect timely and appropriate regulatory change management of CMC changes, including those of increasing complexity and/or business impact, in accordance with the Corporate Change Management Procedures. Support Local Change Review Committees at manufacturing sites in their evaluation of the impact of a CMC change. Assess the regulatory impact of CMC changes on the US NDA. Define CMC documents needed to support the change. Contribute to the maintenance of BI’s databases on post approval requirements (e.g., Variations database for US requirements).
sNDA Submissions: Review, and approve regulatory documents for submission, construct in eCTD format, and file supplemental NDA (sNDA) submissions for CMC changes, including those of increased complexity and/or business impact, and support their approval by FDA. Ensure CPD-3 database accurately reflects the submitted/approved CMC information. Manage the resolution of comments from FDA with assistance from the Director/delegate CMC RA as needed.
NDA Post Marketing Reports:
NDA Annual Report: Manage the preparation, content finalization and submission of the NDA Annual Report, each year within 60 days of the anniversary date of U.S. approval of the NDA application.
Periodic Adverse Experience Reports (e.g. PADER, PBRER) - review the reports for potential CMC impact to safety of the product.
NDA Field Alert Report: Contribute to assessment of potential quality defects, technical product complaints and/or patient complaints and participate (with support from line management) in internal committees for decision making on FARs, potential market impact and communication to FDA as appropriate.
FDA Liaison: As applicable, under the supervision of experienced personnel, will liaise with FDA in written communication and participate in FDA meetings on regulatory issues. Will support/assist in the preparation of cross-functional teams for FDA interactions on regulatory issues and provide guidance on preparation of briefing packages.
DMFs: Act as US Agent for BI’s Type II DMFs incorporated into marketed and established products; prepare and submit Type II DMF amendments and the DMF Annual Report on behalf of the DMF Holder
As member of Product Labeling Review Team (PLRT) and in collaboration with US RA Labeling Content, provide CMC regulatory support during Annual, CCDS, or ad-hoc product labeling reviews for marketed products. Provide input on Country of Origin markings as needed. Participate in management of investigational product labeling by contributing information on CMC particulars (e.g., composition, storage conditions).
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 impact of regulatory guidelines on ongoing work/projects
Strong interpersonal skills, agility and willingness to adapt to a changing environment
Problem solving skills
Excellent oral and written communication skills with the ability to provide key messages in a concise and understandable 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.