(Archived) Manager, Global Regulatory Affairs CMC Pharma

Description: Work as part of a team and prepare, review and files regulatory submissions to appropriate regulatory agencies. Maintain working knowledge of regulations, policies, and guidelines with appropriate agencies. Guide the company in achieving product registrations and for additional/extended claims to existing products, maintaining regulatory compliance and supporting local/global pharma development teams. Provide leadership, development and support to team members in the group. 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: Prepare, review and file regulatory submissions of the CMC section such as full Part 2/CMC Technical Sections (INAD/NADA/MAA’s), variations, supplements, MCSR’s and responses to authorities questions. Provide support for local/international regulatory needs in alliance with global business objectives. Provide guidance/direction/training to other departments relative to in-depth and current understanding of regulatory compliance, submission requirements, time lines or EMEA, U.S. and international regulatory expectations. Assure regulatory compliance and interpretation of regulatory issues to assure excellence in R&D and Manufacturing. Be part of team with R&D, Operations, QA, and Legal in assuring quality and compliance with Internal Manufacturing and third party manufacturers (CMOs). Provide guidance and consultation on product development, including active project team participation and support. Support business development opportunities through evaluation of potential licensing compounds and provide CMC regulatory assessment. Provide guidance/direction within the regulatory department, to other departments and to internal manufacturing sites/CMOs, relative to regulatory compliance of BIAH products and processes. Work with and develop professional relationships with regulatory agency contacts and regulatory groups; discuss and negotiate issues with regulatory agencies; act as primary liaison to regulatory agencies and BI Regulatory Teams for local/foreign registrations; Establish collaborative and productive relationships with key functional players within Boehringer Ingelheim and CMOs. Understand/monitor regulatory trends and work with team to influence legislation/guidance and to inform organization of new guidelines, directives, and agency initiatives. Acts as RA Subject Matter Expert regarding cGMPs and USP/EP. Participate in drafting and review of departmental processes and SOPs for activities relevant to this position and participates in special projects as assigned. Align with global, regional, and local regulatory objectives and execute as per plan. 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 eight (8) years regulatory experience, or twelve (12) years other relevant work experience within pharma With MS/PhD/PharmD: Minimum five (5) years regulatory experience, or eight (8) years other relevant work experience within pharma Regulatory certification or degree preferred 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”. Willing to travel, both domestic and internationally up to twenty (20) percent of the time Accountability: Role model BI Values, by always doing what you say, and saying what you think. Make timely decisions with well-balanced analysis and intuition, particularly in tough situations. Ruthlessly prioritize, then drive execution excellence through discipline and collaboration. Actively give and seek feedback; leverage each other’s strengths to deliver results and develop every individual. Agility: Search and respond to drivers of changes, through active experimentation. Challenge the status quo and assumptions of your own and others, with no political bias. Quickly turn data into insights and insights into actions. Learn with an open mind, and rarely make the same mistake twice. Must have knowledge and experience developing and successfully executing regulatory strategies; and demonstrated understanding of regulations and processes as they apply to drug development and/or product maintenance. Experience is preferred in interacting and communicating with major regulatory agencies in all stages and proven ability to discuss scientific aspects of the program with those agencies. Must have strong business acumen and demonstrate diplomacy in all interactions. Independent and multidisciplinary problem detection and initiation of problem solution. Direct knowledge of regulatory requirements for demonstration of safety and effectiveness, including principals of study conduct, statistics and design preferred. Professional customer focused approach. Prioritizes, manages time, and works independently to meet or exceed agreed upon projects/timelines. Knowledge of US and international CMC regulatory requirements Recognized as expert by clients and acts as a resource for colleagues. Ability to resolve issues, lead teams and render appropriate judgment in scientific, regulatory and technical matters. Conflict resolution and negotiation skills, respectful interactions with individuals with diverse views or backgrounds. High degree of detail orientation and excellent verbal and written communication skills; good interpersonal skills; does not hesitate to actively participate and provide regulatory assessments in meetings. Incumbent should be competent and well-versed in the comprehension and application of the various regulations concerning manufacturing and registration of veterinary pharmaceuticals and pesticides. Intrapreneurship: Serve the needs of customers and patients by turning innovative ideas into business results. Take smart risks by leveraging all possible opportunities - including resources and talents. Demonstrate winning spirit through creating a can-do attitude and positive energy among others. Deliver high quality results, despite challenging conditions. 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 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. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.