Description

　　Associate Manager, Global Regulatory Affairs CMC Pharmaceutical

　　Prepare, review and file regulatory submissions to appropriate regulatory agency with guidance from senior team members. Maintain working knowledge of regulations, policies, and guidelines with appropriate agencies. Manage regulatory requirements, options and timelines to achieve product registrations and additional/extended claims for existing products, maintaining regulatory compliance and supporting local/global pharma development teams.

　　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

　　Review scientific/technical information related to regulatory submissions. Prepare and file regulatory submissions to appropriate regulatory agencies.

　　Oversee the review of change controls for batch production records, raw materials, packaging components and finished product specifications, analytical methods and SOPs and determine filing category and impact to registrations.

　　Maintains advanced and current knowledge of relevant regulations, policies, and guidelines and acts as Regulatory Affairs Subject Matter Expert in assigned areas. Provides guidance/direction within the regulatory department, internal departments and CMOs relative to regulatory compliance of BIAH products and processes.

　　Support OPUs to secure and maintain registrations for pharmaceutical products.

　　Together with colleagues, support and maintain relevant regulatory databases (Corporate Product Database, Archive system). Assist in development and review of department procedures. Supports management for internal audits, agency inspections, etc.

　　Requirements

　　Bachelors degree from an accredited institution with a focus in Chemistry, Pharmaceutics, or Biology preferred, and six (6) years relevant experience

　　Regulatory certification 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 ten (10) percent of the time

　　Must have knowledge of and understanding of regulatory strategies; and demonstrated understanding of regulations and processes as they apply to drug development and/or product maintenance.

　　Must have strong business acumen and demonstrate diplomacy in all interactions.

　　Professional customer focused approach.

　　Prioritizes, manages time, and works independently to meet or exceed agreed upon projects/timelines.

　　Solid 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 various Regulations concerning manufacturing and registration of veterinary pharmaceuticals and pesticides.

　　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.

　　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.

　　Desired Skills, Experience and Abilities

　　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.

　　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.