Boehringer Ingelheim Associate Director / Sr. Associate Director, US SubTeam Member Regulatory Affairs Product Group in RIDGEFIELD, Connecticut

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.

Candidate will be hiredcommensurate with level.

Associate Director &Senior Associate Director Description:

With supervision for assigned development projects and US marketed products, provide experienced US regulatory leadership to the global and US cross-functional teams. Provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance.

  • Act as primary company liaison with the US Food andDrug Administration

  • Provide analysis, advice and guidance on US regulatorystrategies.

  • Provide expertise on regulatory standards and departmentalpolicies

  • Utilize resources consistent with the overall goals andobjectives of the (G) RA department.

  • Maintain current expertise on developments in theassigned therapeutic area from the global regulatory, legislative,scientific, medical, pharmaceutical, pharmacovigilance, market access andcommercial perspective.

Duties &Responsibilities:

  • Regulatory Professionalism : As a regulatory professional with basicknowledge in one or more therapeutic areas, interact effectively at alllevels of the organization (local and global), within Regulatory Affairsand across functions, as a US regulatory advocate to achieve common goalsfor assigned projects, with supervision.

  • RA Sub teams and Intra-RA Project Responsibilities : With supervision: Effectively contributeUS operational and strategic perspectives to RA sub team to ensure TMRAand the sub team accurately considers US regulatory requirements andchallenges in the global context.

  • Present or support review of US-specific regulatorytopics to Regulatory Expert Group (REG), as appropriate.

  • Ensure US RA contributions to all local and globalproject related documentation such as management summaries, TALC / HPSC /DC pre-reads, are clear, complete and accurate, taking on leadership ofthe information as appropriate.

  • Global Project Team Support : In collaboration with the TM RA and RA subteam, provide experienced leadership in the development and implementationof US regulatory strategy within a global development context (withsupervision).

  • Assess US strategic options and provide US regulatoryadvice to support assigned global development projects and ProductMaintenance Optimization strategies, seeking US project team/managementalignment as appropriate (with supervision).

  • Assess opportunities for expedited US regulatorypathways. Define US strategic considerations in the generationof a Global Regulatory Strategy Document.

  • In cooperation with US/Global Labeling, provideproject-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 ofdocumentation, as appropriate

  • US-Focused Project Team Support : With supervision: Provide US regulatorystrategic input and advice to US cross-functional teams duringdevelopment, registration, and marketing approval. Includes,for example, detailed assessment of potential labeling claims to supportUS commercial activities based on clinical trial design and results, ifavailable, taking into account US regulatory labeling precedence and FDAcomments/guidance.

  • Provide US RA leadership in line with approvedprocesses to prepare initial proposed draft labeling for submission toFDA. Ensuring appropriate supportive information is provided.

  • Health Authority Interactions/Submissions : With supervision: Responsible forall FDA interactions on assigned projects/products, including formalmeetings, FDA review of registration packages, and labelingnegotiations.

  • Establish and implement US regulatory strategy andgoals for formal meetings with FDA that is aligned with project teams andRA Sub team.

  • Provide regulatory leadership to ensure alignment withglobal and US team/management, as appropriate, in preparing responses toFDA requests.

  • Lead FDA meetings for assigned projects

  • Disseminate FDA interactions within BI, as appropriate.

  • Manage all formal submissions and informalcommunications to FDA for assigned projects/products, including clinicaltrial and marketing authorization applications.

  • Other Regulatory Contributions : With supervision: Provide USstrategic regulatory guidance and input to key internal development,registration and commercialization documents for assigned projects (e.g.development plans, protocols, clinical trial reports, pediatricdevelopment plans, core dossier elements, integrated brand plans, marketaccess documents, with particular emphasis on the US contribution withinthe strategic country prioritizations (i.e., “hyperfocus”).

  • Provide US regulatory leadership in the preparation,content, and distribution in the US of critical safety or qualitycommunications (including DHCP letters) for assigned projects/products,with guidance from management, TM RA, US Legal, and GPV, as appropriate.

  • As defined by respective BI processes, review andrelease, via cross-functional medical-legal-regulatory team, US coremessages, as appropriate (e.g., press release, stand-by statements).

  • Regulatory Intelligence:

  • Proactively review and evaluate relevant US regulationsand guidelines, as well as evolving regulatory trends and developments fortheir impact on drug development activities and on existing developmentstrategies.

  • Share new/novel "on the job" US regulatoryintelligence/experience with peers, as appropriate

Associate Director Requirements:

  • Minimum requirements :Bachelor’s degree from an accredited institution in life sciences,pharmacy, or chemistry with drug development experience/knowledge.

  • Preferred requirements : Doctoral Degree (e.g. PhD) and/or Master’s degreefrom an accredited institution in life sciences, pharmacy, or chemistry,with drug development experience/knowledge

  • Critical thinker with ability to self-direct workload,including reprioritizing and delivery under tight timelines.

  • Ability to analyze and interpret scientific data andregulatory guidelines

  • Strong interpersonal skills supporting the ability toinfluence without authority, develop effective professional relationships,work in a matrixed team environment, and demonstrate sound conflictmanagement and negotiation skills along with the flexibility andwillingness to adapt to a changing environment

  • Excellent oral, written and presentation skill with theability to provide key messages in a concise manner.

  • Demonstrated understanding of the regulatory processand technical competence in core areas of drug development.

  • Requires relevant US regulatory experience andknowledge, from both strategic and operational perspectives.

  • Basic knowledge in RA gained through direct regulatoryliaison with US FDA

  • Understanding of and fluency with:

  • Food, Drug and Cosmetic Act

  • 21 CFR regulations relevant to drug/biologicdevelopment and registration

  • Other relevant US laws, regulations and guidancedocuments

  • Medical, pharmaceutical and scientific knowledge andunderstanding in the assigned therapeutic area. Extensiveexperience demonstrated in managing all aspects of FDA liaison activities(e.g., submission strategies, FDA meeting “management”, AdComm participation/leadership)

  • RAC certification preferred

Senior AssociateDirector Requirements:

  • Minimum requirements :Bachelor’s degree from an accredited institution in life sciences,pharmacy, or chemistry with extensive drug developmentexperience/knowledge.

  • Preferred requirements : Doctoral Degree (e.g. PhD) and/or Master’s degreefrom an accredited institution n life sciences, pharmacy, or chemistry,with some drug development experience/knowledge

  • Critical thinker with ability to self-direct workload,including reprioritizing and delivery under tight timelines.

  • Ability to analyze and interpret scientific data andregulatory guidelines

  • Strong interpersonal skills supporting the ability toinfluence without authority, develop effective professional relationships,work in a matrixed team environment, and demonstrate sound conflictmanagement and negotiation skills along with the flexibility andwillingness to adapt to a changing environment

  • Excellent oral, written and presentation skills withthe ability to provide key messages in a concise manner.

  • Demonstrated understanding of the regulatory processand technical competence in core areas of drug development.

  • Requires a robust and broad range of US regulatoryexperience and knowledge, from both strategic and operationalperspectives.

  • (In-depth)knowledge in RA gained through direct regulatory liaison with US FDA

  • Understanding of and fluency with:

  • Food, Drug and Cosmetic Act

  • 21 CFR regulations relevant to drug/biologicdevelopment and registration

  • Other relevant US laws, regulations and guidancedocuments

  • Medical, pharmaceutical and scientific knowledge andunderstanding in the assigned therapeutic area. Extensiveexperience demonstrated in managing all aspects of FDA liaison activities(e.g., submission strategies, FDA meeting “management”, AdCommparticipation/leadership

  • RAC certification preferred

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

EligibilityRequirements:

  • Must be legally authorized to work in the United Stateswithout restriction.

  • Must be willing to take a drug test and post-offerphysical (if required)

  • Must be 18 years of age or older

Our Culture:

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Merial Barceloneta, 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; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.

Organization: US-BI Pharma/BI USA

Title: Associate Director / Sr. Associate Director, US SubTeam Member Regulatory Affairs Product Group

Location: Americas-United States-CT-Ridgefield

Requisition ID: 183226