Boehringer Ingelheim Senior Specialist, Regulatory Affairs in ATHENS, Georgia
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.
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 R&D for regulatory aspects of the veterinary biologics portfolio supply chain defense and life cycle management.
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 lifecycle management.
To remain current with regard to domestic and international laws, regulations, guidelines and/or policy that may impact Boehringer Ingelheim veterinary biologics and recommend appropriate action to protect the Company's interests. In accordance with applicable regulatory requirements and the registration plans she/he creates and maintains 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, R&D, Pharmacovigilance, 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 Merial’s 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 in Athens and Gainesville, Georgia
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
Bachelor’s degree in areas of biomedical sciences (biology, microbiology, molecular biology, immunology, etc.), or equivalent advanced training/experience in these disciplines
Master’s degree preferred.
1 year or more of 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. 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
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
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, 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.
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.
Title: Senior Specialist, Regulatory Affairs
Requisition ID: 1816041