Post Doctoral Fellow Regulatory Affairs - Chemistry, Manufacturing & Control - Boehringer Ingelheim
Ridgefield, CT
About the Job
Description
The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to -- Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require the Fellow to develop competencies necessary to contribute to their respective functional area within a pharmaceutical company. The Fellow will be based at Boehringer Ingelheim´s U.S. headquarters in Ridgefield, CT, working on a particular or multiple therapeutic areas (TAs) in the areas of cardiology, diabetes, immunology, oncology, and respiratory. Through a series of rotations either within or outside of the assigned area, the Fellow will also gain an understanding of the broad range of opportunities available to a pharmacist in the pharmaceutical industry. 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.
The Regulatory Affairs (RA) Fellowship within the Chemistry, Manufacturing and Controls (CMC) discipline is designed to provide pharmacists with a 2-year exposure to the regulatory aspects of CMC during the lifecycle 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 early phase US INDs. Under supervision, the Fellow will:
• Act as a company liaison with the US Food and Drug Administration.
• Research information on regulatory CMC standards and departmental policies.
• Provide strategic regulatory input as it pertains to US Marketed Products
• Author, review and update CMC documentation US registered products.
Duties & Responsibilities
Regulatory Expertise:
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 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).
+ CPD3 compliance: Ensure CPD-3 database accurately reflects the approved/dispatched CMC information.
Position Expertise:
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.
Application Requirements
1. Curriculum vitae
2. Letter of intent - focusing on how a fellowship at Boehringer Ingelheim can help further your career growth. * Please upload under My Documents, Additional Attachments.
Requirements
+ Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned prior to the start date at Boehringer Ingelheim.
+ Ability to perform MEDLINE and EMBASE literature searches.
+ Strong intrapersonal, active listening, and problem-solving skills with an ability to work well in a team environment.
+ Highly motivated and shows initiative in contributing to team deliverables.
+ Receptive to receiving and quickly implementing constructive feedback.
+ Ability to work independently within provided guidance from team leads.
+ Adaptable and able to contribute to multiple Therapeutic Areas as needed.
+ Excellent verbal and written communication skills.
+ Proven experience working in a dynamic, high volume environment handling multiple tasks.
+ Strong computer skills, including Outlook, Word, PowerPoint, and Excel.
+ Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy with an ability to quickly adapt to a changing Corporate environment that will allow the incumbent to be productive in rotational experiences.
Desired Experience, Skills, and Abilities:
+ Prior pharmaceutical industry experience (e.g. internship or Advanced Pharmacy Practice Experience [APPE] rotation is preferred but not required.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to -- Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require the Fellow to develop competencies necessary to contribute to their respective functional area within a pharmaceutical company. The Fellow will be based at Boehringer Ingelheim´s U.S. headquarters in Ridgefield, CT, working on a particular or multiple therapeutic areas (TAs) in the areas of cardiology, diabetes, immunology, oncology, and respiratory. Through a series of rotations either within or outside of the assigned area, the Fellow will also gain an understanding of the broad range of opportunities available to a pharmacist in the pharmaceutical industry. 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.
The Regulatory Affairs (RA) Fellowship within the Chemistry, Manufacturing and Controls (CMC) discipline is designed to provide pharmacists with a 2-year exposure to the regulatory aspects of CMC during the lifecycle 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 early phase US INDs. Under supervision, the Fellow will:
• Act as a company liaison with the US Food and Drug Administration.
• Research information on regulatory CMC standards and departmental policies.
• Provide strategic regulatory input as it pertains to US Marketed Products
• Author, review and update CMC documentation US registered products.
Duties & Responsibilities
Regulatory Expertise:
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 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).
+ CPD3 compliance: Ensure CPD-3 database accurately reflects the approved/dispatched CMC information.
Position Expertise:
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.
Application Requirements
1. Curriculum vitae
2. Letter of intent - focusing on how a fellowship at Boehringer Ingelheim can help further your career growth. * Please upload under My Documents, Additional Attachments.
Requirements
+ Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned prior to the start date at Boehringer Ingelheim.
+ Ability to perform MEDLINE and EMBASE literature searches.
+ Strong intrapersonal, active listening, and problem-solving skills with an ability to work well in a team environment.
+ Highly motivated and shows initiative in contributing to team deliverables.
+ Receptive to receiving and quickly implementing constructive feedback.
+ Ability to work independently within provided guidance from team leads.
+ Adaptable and able to contribute to multiple Therapeutic Areas as needed.
+ Excellent verbal and written communication skills.
+ Proven experience working in a dynamic, high volume environment handling multiple tasks.
+ Strong computer skills, including Outlook, Word, PowerPoint, and Excel.
+ Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy with an ability to quickly adapt to a changing Corporate environment that will allow the incumbent to be productive in rotational experiences.
Desired Experience, Skills, and Abilities:
+ Prior pharmaceutical industry experience (e.g. internship or Advanced Pharmacy Practice Experience [APPE] rotation is preferred but not required.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Source : Boehringer Ingelheim
