Boehringer Ingelheim
Post-Doctoral Regulatory Affairs Fellow - Policy and Intelligence
Boehringer Ingelheim, Ridgefield, Connecticut, us, 06877
Post‑Doctoral Regulatory Affairs Fellow – Policy and Intelligence
Join us at Boehringer Ingelheim to build your career as a post‑doctoral pharmacist. In this role, you will receive broad exposure to our US Medical functions, including Medical Affairs, Scientific Communications, clinical operations, translational medicine, clinical pharmacology, and regulatory affairs. You will work in Ridgefield, CT, on therapeutic areas such as cardiology, diabetes, immunology, oncology, and respiratory and gain a comprehensive understanding of the opportunities available to a pharmacist in the pharmaceutical industry.
Description 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 also offers 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 Boehringer Ingelheim.
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 Regulatory Affairs.
Research and implement processes to improve regulatory intelligence and collaboration.
Develop expertise on projects from the regulatory intelligence and policy perspective.
Collaborate with Boehringer Ingelheim Government Affairs to ensure knowledge sharing of overlapping intelligence topics.
Regulatory Expertise The Fellow will develop basic regulatory policy and intelligence knowledge across the spectrum of Boehringer Ingelheim assets and marketed products. With supervision, the Fellow will:
Review and evaluate relevant US regulations and guidelines, and evolving regulatory trends and developments for their impact on drug and device development activities.
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 compliance and process initiatives.
Own the review and refinement of regulatory FDA guidance and recommendations, developing written comments reflecting Boehringer Ingelheim’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 Regulatory Affairs colleagues on drug development, 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 Regulatory Affairs 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 Boehringer Ingelheim’s positions by trade organizations.
Collaborate with Government Affairs to shape emerging legislative proposals.
Develop targeted and appropriate automation of regulatory information.
Position Expertise
Basic knowledge of pharmacy, gained through a Doctor of Pharmacy program.
Basic understanding of the 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.
Qualifications
Doctor of Pharmacy degree from an ACPE‑accredited school or college of pharmacy earned prior to the start date.
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 initiative‑driven to contribute to team deliverables.
Receptive to receiving and quickly implementing constructive feedback.
Able 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 the 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 rotation is preferred but not required).
Application Requirements
Curriculum vitae.
Letter of intent focusing on how a fellowship at Boehringer Ingelheim can help further your career growth.
Job Details
Seniority level: Internship
Employment type: Full‑time
Job function: Research, Analyst, and Information Technology
Industry: Pharmaceutical Manufacturing
Location: Ridgefield, CT
Boehringer Ingelheim With Boehringer Ingelheim, you can develop your own path in a company that values differences as strengths and transforms lives worldwide. We support employee development, work‑life balance, and professional growth through international collaboration and strong benefits.
#J-18808-Ljbffr
Description 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 also offers 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 Boehringer Ingelheim.
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 Regulatory Affairs.
Research and implement processes to improve regulatory intelligence and collaboration.
Develop expertise on projects from the regulatory intelligence and policy perspective.
Collaborate with Boehringer Ingelheim Government Affairs to ensure knowledge sharing of overlapping intelligence topics.
Regulatory Expertise The Fellow will develop basic regulatory policy and intelligence knowledge across the spectrum of Boehringer Ingelheim assets and marketed products. With supervision, the Fellow will:
Review and evaluate relevant US regulations and guidelines, and evolving regulatory trends and developments for their impact on drug and device development activities.
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 compliance and process initiatives.
Own the review and refinement of regulatory FDA guidance and recommendations, developing written comments reflecting Boehringer Ingelheim’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 Regulatory Affairs colleagues on drug development, 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 Regulatory Affairs 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 Boehringer Ingelheim’s positions by trade organizations.
Collaborate with Government Affairs to shape emerging legislative proposals.
Develop targeted and appropriate automation of regulatory information.
Position Expertise
Basic knowledge of pharmacy, gained through a Doctor of Pharmacy program.
Basic understanding of the 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.
Qualifications
Doctor of Pharmacy degree from an ACPE‑accredited school or college of pharmacy earned prior to the start date.
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 initiative‑driven to contribute to team deliverables.
Receptive to receiving and quickly implementing constructive feedback.
Able 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 the 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 rotation is preferred but not required).
Application Requirements
Curriculum vitae.
Letter of intent focusing on how a fellowship at Boehringer Ingelheim can help further your career growth.
Job Details
Seniority level: Internship
Employment type: Full‑time
Job function: Research, Analyst, and Information Technology
Industry: Pharmaceutical Manufacturing
Location: Ridgefield, CT
Boehringer Ingelheim With Boehringer Ingelheim, you can develop your own path in a company that values differences as strengths and transforms lives worldwide. We support employee development, work‑life balance, and professional growth through international collaboration and strong benefits.
#J-18808-Ljbffr