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Boehringer Ingelheim Senior Associate Director/Director, Global Regulatory Lead - CNS / Retinopathy and Emerging Areas 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.

Senior Associate Director / Director, Global Regulatory Lead- CNS / Retinopathy (Remote)

Level commensurate with candidate Qualifications

Join our highly collaborative and experienced Regulatory Affairs team as we work with colleagues across our family owned organization to help bring new medical advancements to patients. This position, home based office in Boehringer Ingelheim’s Ridgefield, Connecticut site, will serve as the Global Regulatory Lead for assigned development projects, leading the international regulatory subteam to provide regulatory strategy and support to the international core project team and associated discipline subteams. The ideal candidate will be a seasoned regulatory professional who has demonstrated effective leadership and in-depth expertise for a broad range of global regulatory and drug development topics so as to successfully manage complex projects and/or sensitive topics.

Description:

Provide strategic regulatory guidance to the Core Team and other discipline’s respective sub teams, challenge development/PMO programs scientifically and manage all regulatory aspects through the development of new medicinal products, new indications or PMO projects as well as the maintenance period; be accountable for the global development of investigational products towards submission, approval, and coordination of regulatory maintenance activities taking into account and being compliant to respective drug laws.

Lead regulatory sub teams of global drug or device projects, potentially with the involvement of licensing partners, representing Global Regulatory Affairs in the Core Team of a project and project related sub teams (e.g. PVWG) and provide global leadership and strategic planning in order to ensure sound regulatory practices are integrated into international drug development programs for assigned NCE/NBEs or PMO projects.

Follow regulatory standards, provide analysis, advise on and implement regulatory strategies and departmental policies and utilize resources consistent with the overall goals and objectives of the GRA department as well as keep up to date on developments in the assigned therapeutic area from the global regulatory, scientific, and pharmaceutical, pharmacovigilance, market access and commercial perspective.

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

Duties & Responsibilities:

  • Regulatory Professionalism: As an expert in regulatory affairs and preferably in the assigned Therapeutic Area, interact effectively at all levels of the organization, within Regulatory and across functions, as a convincing advocate to achieve common goals for assigned projects.

  • RA Sub teams: Effectively lead RA Sub teams. Convey up to date project information to ensure sub team members can fulfill their assigned tasks as well as seek input from RA sub team functions to accurately reflect global regulatory requirements and challenges in the Core Team. Generation and alignment within RA sub team of RSUs, ORION meeting content and timings, management briefings (PURs) as well as pre-reads and presentation at the Regulatory Expert Group (REG). Responsible for the GRA contribution to all project related documentation such as the management summary.

  • Global Regulatory Strategy: In collaboration with the RA sub team lead the development and implementation of sound global regulatory strategy. Present and assess strategic options and provide regulatory advice to support assigned development projects and Product Maintenance Optimization strategies, taking into account the global goals and the regional requirements considering, where appropriate, expedited regulatory pathways. Lead generation of a Global Regulatory Strategy document and coordinate the input from RA sub team members as well as ensure GRS endorsement by appropriate GRA functions/bodies.

  • External/internal assessments, external partners : Participate and support internal and external pre-evaluations (e.g. Due Diligence) and contribute to assessment reports. For projects with a licensing partner fulfill RA tasks (e.g. chair of regulatory teams etc.) as outlined in the licensing contract

  • HA Meetings: Establish global strategy and goals for formal meetings with health authorities for drug development goals in alignment with Core Team as well as RA Sub team, adjusted during the course of development as needed. Support the respective Local Regulatory Leads (LRL) in defining the regional-specific questions and content. In strong collaboration with the respective LRL provide guidance and input to various types of regulatory agency meetings including preparation of briefing documentation (e.g. scientific advice, EoP II, pre-submission meetings) as well as planning the actual meeting. Attend Health Authority meetings for assigned projects as appropriate.

  • General global regulatory considerations: Provide global strategic regulatory guidance and input to key development, registration and commercialization documents for assigned projects (e.g. development plans, protocols, clinical trial reports, CTAs, pediatric development plans and applications, core dossier elements, integrated brand plans, market access documents, with particular emphasis to company’s overall hyper focus and focus country prioritization.

  • In cooperation with Global Labelling , provide project-related global regulatory input into content of the draft CCDS; support LRLs in regional/local discussions related to the content of drug labelling (e.g. EU SmPC and US PI), during development, submission preparation, submission review and product lifecycle.

  • Provide global regulatory leadership in the preparation, content and distribution of critical safety or quality communications for assigned projects, coordinating simultaneous and content harmonized communications to HAs and, in conjunction with TM Medicine, ECs/IRBs and investigators. In addition for marketed products, provide coordination and guidance, resulting in communications to Health Care providers, e.g. through DHCPs.

  • Maintain global oversight of local RA activities in responding to local health authority questions to assigned projects, providing global regulatory guidance and input (e.g. MAAs/NDAs/BLAs, Extensions, CTAs, Variations/supplements, PIPs/PSPs, labelling) as appropriate.

  • Support submission rollout for RoW countries from the global strategic perspective with particular emphasis to company’s overall focus country prioritization.

  • Review and release via cross-functional medical-legal-regulatory team of global core messages defined by respective BI process

  • Regulatory Intelligence: Proactively evaluate relevant worldwide regulations and guidelines, as well as evolving regulatory trends and developments, critically for their impact on drug development activities and determine impact on existing strategies.

  • Develop and advise on contingency plans for assigned projects as necessary.

  • Provide timely risk/benefit analyses of issues affecting products/projects by continued monitoring of available regulatory and competitor information.

  • Might be an internal regulatory topic lead or participant in cross-functional working groups to represent GRA.

  • Mentoring: Mentoring other GRA functions including RA sub team members and provide education to pharmacy students

Senior Associate Director:

Requirements:

  • Minimum requirement : Bachelor’s degree from an accredited institution in pharmacy, life sciences or chemistry

  • Preferred requirements : Master’s degree or Doctoral degree (e.g. PhD) from an accredited institution in pharmacy, life sciences or chemistry.

  • Further degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs

  • Five (5) years’ experience in regulated pharmaceutical industry

  • 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

  • Ability to work well under pressure, influence without authority, strong interpersonal skills, relationship building, works in a team environment, sound conflict management skills, flexibility and willingness to adapt in a changing environment

  • Leadership, sound decision-making, negotiation and problem solving skills in an independent manner with an overall strategic view and strong business acumen.

  • Excellent oral and written communications skills with the ability to provide key messages in a concise manner.

  • In-depth knowledge in RA gained through direct regulatory liaison in at least one major region and experience in RA requirements/tasks in at least two regions, preferably one of them EU or US.

  • Medical, pharmaceutical and scientific knowledge and understanding preferably in the assigned therapeutic area

  • Global Regulator Lead will represent GRA in the Core Team as the globally responsible person. As such understands the processes and procedures within GRA as well as the global regulatory requirements to be able to represent GRA in the Core Teams/other cross functional teams.

  • Global Regulatory Lead expertly leads the regulatory sub team to ensure definition and implementation of sound regulatory strategies throughout development and post-approval.

Director:

Requirements:

  • Minimum requirement : Bachelor’s degree from an accredited institution in pharmacy, life sciences or chemistry

  • Preferred requirement: Master’s Degree or Doctoral Degree (e.g. PhD) from an accredited institution in pharmacy, life sciences or chemistry.

  • Preferred: Additional degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification

  • Ten (10) years’ experience in regulated pharmaceutical industry

  • In-depth knowledge in RA gained through direct regulatory liaison in at least one major region and experience in RA requirements/tasks in at least two regions, preferably one of them EU or US.

  • “Fluent” medical, pharmaceutical and scientific knowledge and understanding preferably in the assigned therapeutic area

  • Global Regulatory Lead will represent GRA in the Core Team as the globally responsible person. As such understands the processes and procedures within GRA as well as the global regulatory requirements to be able to represent GRA in the Core Teams/other cross functional teams.

  • Global Regulatory Lead expertly leads the regulatory sub team to ensure definition and implementation of sound regulatory strategies throughout development and post-approval.

  • May serve in the capacity of local (US) Regulatory Area Lead (RAL) [see specific profile for additional responsibilities associated with this function]

Eligibility Requirements:

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)

Must be 18 years of age or older

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.

Want to learn more? Visit boehringer-ingelheim.com at http://www.boehringer-ingelheim.com/ and join us in our effort to make more health.

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.

PDN2

Organization: US-BI Pharma/BI USA

Title: Senior Associate Director/Director, Global Regulatory Lead - CNS / Retinopathy and Emerging Areas

Location: Americas-US-CT-Ridgefield

Other Locations: Americas-United States

Requisition ID: 2013353

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