Boehringer Ingelheim Manager, Regulatory Labeling in SAINT JOSEPH, Missouri
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.
Lead and manage Regulatory Affairs Labeling team members for pharmaceutical (FDA/EPA) labeling, in line with the appropriate regulatory requirements, BI policies, business strategies and priorities.
Provides technical and strategic labeling guidance to project teams, internal departments, Operative Units (OPUs), and third parties. Serves as point of contact for regulatory labeling for other RA teams (particularly the USA RA product managers), Commercial Operations, local RA managers in OPUs (Operative Units), Supply Chain, Packaging Operations and other functions as appropriate, and coordinates activities with these teams.
Responsible for coordinating the creation and review of labeling materials for BI domestic and export markets, including relevant distributors or contract manufacturers. Ensures compliance with US government agency labeling regulations set by the FDA/EPA per the scope of the position's responsibilities. Interfaces with regulatory authorities and industry associations in the scope of the position's responsibilities.
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:
Personnel management responsibilities including: recruiting, coaching, mentoring, talent development, performance management, and compensation planning for Specialists, Senior Specialists, and Principal Specialists as applicable.
Manage external vendors or temporary personnel which may be contracted to perform functions.
Provide leadership and support for daily operations functions related to label review and release to Packaging. Manage team workload, provide prioritization and cooperation across sites with cross-functional capabilities. Identify staffing or outsourcing needs.
Completion of new labeling for product launches and revisions for product maintenance, efficiently and accurately.
Provide technical and strategic regulatory labeling advice to internal and external stakeholders, including launch teams, project teams, BI Operative Units, and other BI departments. Proactively identify labeling issues to avoid gaps, delays, or non-compliance. Provide timely answers to specific requests, or direction to an appropriate source for answers.
Development and maintenance of USA labeling texts in accordance with applicable regulatory agency requirements, in close collaboration with RA product managers. Proactively identify any issues or complications, liaise with colleagues, and provide recommendations or solutions as needed.
Draft, review, update of department working instructions and SOPs for activities relevant to this position. Oversee training of new hires and temporary workers.
Participate in Industry/Agency conferences and forums. Review draft regulations pertaining to labeling, providing input regarding problem items, gaps, and improvements.
Serves as a labeling expert contact for relevant company and corporate systems, evaluation and implementation.
Bachelor’s Degree, preferably in science, plus 5 years of relevant industry experience or 3 years of relevant regulatory experience
Established track record of working within regulated veterinary medicine industry environments and within complex international team environments
Experience working in teams, across functions and being able to influence and negotiate with stakeholders to achieve results
FDA and/or EPA regulatory experience
Ability to lead people, demonstrated either formally with prior positions or informally via work experience
Proficient in standard office technology, including Word, Excel, and Adobe Acrobat
Strong written and verbal communication skills
Strong attention to detail
Must exhibit good judgement, and ability to problem-solve issues in daily work
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: Manager, Regulatory Labeling
Location: Americas-US-MO-Saint Joseph
Other Locations: Americas-US-GA-Duluth
Requisition ID: 1814790