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Boehringer Ingelheim Associate Director / Manager, Established Products Regulatory Affairs - Remote 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.

Associate Director / Manager, Established Products Regulatory Affairs

The qualified candidate will be hired at the appropriate level commensurate with education/experience.

Description:

The EP Associate Director is responsible for the coordination and execution of regulatory activities required of an NDA Holder for compliance to FDA requirements for U.S. market products in BIPI's established products portfolio. These responsibilities include management of CMC and product labeling changes as well as the preparation and submission of supplemental applications and postmarketing reports per US regulations. Acts as primary internal contact for all US regulatory relevant topics. Additionally, with support and guidance from the Sr. Associate Director, acts as liaison to FDA for routine established product interactions. It is expected that the Associate Director position is capable of support projects of increasing regulatory complexity and/or business impact.

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:

  • CMC Lifecycle Management: Effect timely and appropriate regulatory change management of CMC changes, including those of increasing complexity and/or business impact, in accord 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 the proposed CMC changes on the US NDA. Define CMC documents needed to support the change. Contribute to the maintenance of BI’s databases on postapproval requirements, e.g., Variations database, for US requirements.

  • Labeling: As member of Product Labeling Review Team (PLRT) and in collaboration with US RA Labeling Content, provide regulatory direction during Annual, CCDS, or ad-hoc product labeling reviews.

  • Collaborate with US RA Labeling Content and Labeling Operations to facilitate submission of labeling supplements and implementation of changes to labeling. Provide input on Country of Origin markings as needed.

  • sNDA Submissions: Review, and approve regulatory documents for submission, construct in eCTD format, and file supplemental NDA (sNDA) submissions for CMC and/or labeling changes, including those with increased complexity and/or business impact, and support their approval by FDA. Manage the negotiation of labelling changes with FDA with assistance from the Sr. Associate Director EP as needed.

  • NDA Post Marketing Reports:

  • NDA Annual Report: Manage the preparation and final content 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); Manage the preparation and submission and contribute to content.

  • NDA – Field Alert Report: Contribute to assessment of potential quality defects, technical product complaints and/or patient complaints and participate in internal committees for decision making on FARs, potential market impact and communication to FDA as appropriate.

  • FDA Liaison: Liaise with FDA in written communication and participate in FDA meetings on regulatory issues. Prepare cross-functional teams for FDA interactions on regulatory issues and provide guidance on preparation of briefing packages.

  • CPD3 compliance: Ensure CPD-3 database accurately reflects the approved/dispatched CMC information.

  • DMFs: Act as US Agent for BI’s DMFs incorporated into established products; prepare and submit DMF amendments and the DMF Annual Report on behalf of the DMF Holder.

EP Associate Director Requirements:

  • Minimum BS/BA from an accredited institution required. Chemistry, Biology, Pharmaceutical Science or relevant field of study preferred. An advanced degree from an accredited institution is desirable.

  • With BS/BA: Minimum six (6) years regulatory experience, or other relevant work experience within pharma

  • With M.S.: Minimum four (4) years regulatory experience, or other relevant work experience within pharma

  • With Ph.D.: Minimum two (2) years regulatory experience, or other relevant work experience within pharma

  • Broad knowledge of US regulatory CMC & Labeling requirements and the ability to apply knowledge both strategically and operationally to established marketed product regulatory issues.

  • Minimum two (2) year experience providing direct regulatory support for US NDA marketed products preferred, including experience in CMC and labeling.

  • Excellent communication (verbal, written and presentation) skills

  • Excellent skills in planning, organizing, and problem-solving with developing decision-making skills

  • Excellent interpersonal skills

  • Willing to travel, both domestic and internationally up to ten percent of the time

  • Computer and information technology literacy.

  • Critical thinker with ability to self-manage workload

  • Ability to work well under pressure, influence without decision-making authority, work in a team environment, flexibility to adapt in a changing environment.

  • Detail oriented but also able to see “big picture”.

EP Manager Requirements:

  • Required: Minimum BS/BA. Chemistry, Biology, Pharmaceutical Science or relevant field of study preferred.

  • Min 2 years regulatory experience or other relevant work experience within pharma.

  • Excellent communication (verbal and written) skills

  • Excellent skills in planning, organizing, and problem-solving

  • Willing to travel, both domestic and internationally up to ten percent of the time

  • Computer and information technology literacy.

  • Ability to work well under pressure, work in a team environment, flexibility to adapt in a changing environment.

  • Detail oriented, well organized.

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., 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.

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Organization: US-BI Pharma/BI USA

Title: Associate Director / Manager, Established Products Regulatory Affairs - Remote

Location: Americas-US-CT-Ridgefield

Requisition ID: 2013442

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