Senior Specialist, Regulatory Affairs

Senior Specialist, Regulatory Affairs


Description:

Support all regulatory activities required by federal, state, local, and international laws, as well as internal policies for continued manufacturing, distribution, and sales of veterinary biologics. In a team environment, to provide logistical and tactical regulatory expertise to internal business partners and stakeholders.

To serve as main point of contact for Industrial Operations, Commercial Operations, and Research & Development (R&D) for regulatory aspects of the veterinary biologics portfolio supply chain defense and life cycle management (LCM).

To determine appropriate regulatory requirements, commitments and actions required to support maintenance and defense of existing licensed products and manufacturing sites. To actively participate with non-regulatory team members in integrating the regulatory perspective in project teams related to new product development or LCM.

To remain current with regard to domestic and international laws, regulations, guidelines and/or policy that may impact BIAH veterinary biologics and recommend appropriate action to protect the Company’s interests. In accordance with applicable regulatory requirements and the registration plans, create and maintain abbreviated files for international regulatory submission and provides technical regulatory support to assist timely and efficient registration in all target markets.

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:

  • Support regulatory compliance of licensed biological products throughout their lifecycle, ensuring proper regulatory management of changes, deviations, exemptions, notifications, renewals, and geographic extension in close collaboration with Industrial Operations, Quality Assurance (QA), R&D, Pharmacovigilance (PV), Business Operations, Legal, and others.
  • Support responses to regulatory inspections and government inquiries (domestic and international)
  • Provide regulatory assessments for proposed business and manufacturing changes related to approved biological products in compliance with USDA and international guidelines and regulations
  • Provide regulatory expertise and advice, as appropriate, to other functions or interdisciplinary project teams (in-line product management, launch teams, etc.)
  • Review draft regulatory texts, appropriately comment and propose amendments to draft requirements in alignment with company needs.
  • Maintain work instructions and tools (records, schedules, reports, database, etc.) for timely and efficient management of regulatory activities.
  • Manage and provide oversight for assembly, review, formatting, circulation, approval, and submission of Outlines of Production, Special Outlines, and facility documents to the Center for Veterinary Biologics (CVB) to support compliance and variations
  • Support organization, archiving, and retrieval of regulatory documents and correspondence
  • Help to assemble and provide final QA review for electronic submissions to government agencies through government portal(s) including updating documents to required templates and compliance with electronic record keeping
  • Maintain regulatory databases, activities charting, and government submission and response tracking
  • Support maintaining the official regulatory archives
  • Circulate, compile comments, and provide quality review of internal Policy, Procedures, and Guidelines (PPG)
  • Provide support for miscellaneous project assignments as needed
  • Secure needed import and transport permits or authorizations as needed from local, State, Federal, or international regulatory authorities
  • Manage correspondence with State regulatory authorities
  • Coordinate with international regulatory colleagues on global initiatives for which US input is required
  • Supports regulatory compliance and ensures proper regulatory management of changes, deviations, exemptions, notifications, renewals, and geographic extension in close collaboration with other areas.

Requirements:

  • A Master’s degree from an accredited institution, preferably in area of science, with one (1) year of related industry or regulatory experience
  • Or a Bachelor’s Degree from an accredited institution, preferably in area of science, with a minimum of two (2) years previous relevant industry or regulatory affairs experience.
  • In lieu of either degree, eight (8) years of relevant industry experience and three (3) years relevant regulatory experience.
  • Experience in the pharmaceutical, biologics and/or related industries or disciplines dealing with US local, state, and federal regulatory issues related to in particular those associated with product development, licensure, and maintenance, licensed manufacturing facilities and related industry matters.
  • Must have regulatory knowledge and expertise.
  • Experience interacting with USDA or other government agencies preferred.
  • Excellent communication (verbal and written), negotiation, organizational, and teamwork skills
  • Committed to performance with attention to details
  • Innovative problem solving skills
  • High level of computer skills, including proficiency in Microsoft Word, Excel, Adobe Acrobat

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 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.

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Posted on

June 24, 2020