AD, Global RA Innovation CMC

Description

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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Provides new product and marketed product support in the Global Regulatory Affairs (RA) Chemistry Manufacturing and Controls (CMC) function for  products in line with Company policies, business strategies and priorities in close collaboration with Quality, R&D and Operations/Manufacturing.  Responsible for the CMC technical information submitted to global Health Authorities supporting regulatory filings for assigned new pharmaceutical products and life cycle management of existing products in accordance with Company priorities and governance.  Represents CMC through interactions with other RA groups, Analytical R&D, Formulation Development, Quality and Operations on project teams.  Accountable for new products in development and ongoing technical support to marketed products as it pertains to the preparation and maintenance of the CMC technical section of product applications and licenses worldwide. In collaboration with regional experts, develops strategies for innovative solutions and support systems, coordination of data to support CMC sections for worldwide registrations from early development, including supporting transfer of projects or existing products to new manufacturing sites, as well as assessing and maintaining product compliance with regulatory filings.

Duties & Responsibilities

• With a focus on USDA registration of animal health vaccines, direct the efforts of team members who are responsible for preparing, reviewing and filing regulatory submissions to global Regulatory Authorities.


• Ensure each team member is able to perform their job duties by providing leadership, mentoring, and development opportunities.


• Match projects with team members' experience level and skills ensuring that the objectives of the product team and company are met in the most efficient and compliant manner.


• Provide coaching, training and development to a group of regulatory professionals in order to provide solid succession planning for the future of the team.  Incorporate performance and development plans with company goals in the HR management system.


• Define, plan and manage preparation of CMC submissions and support their approval by regulatory authorities.  Provide support for international regulatory needs in alliance with global business partners and objectives.


• Direct activities needed to assess and resolve risks related to CMC, recommend actions and manage overall processes to provide guidance/direction/training to other departments relative to in-depth and current understanding of regulatory compliance, submission requirements, time lines or Regulatory Agency expectations.


• Assure regulatory compliance and interpretation of regulatory issues to assure excellence in R&D and Manufacturing. Be part of a 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 global CMC regulatory assessment.


• Provide guidance/direction within the regulatory department, to other departments and to internal and external manufacturing sites, relative to regulatory compliance of BIAH products and processes.  Support manufacturing site inspections and provide leadership and advice to Operations and Quality in connection with authority inspections.


• 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 Health Authorities and BI Regulatory Teams for 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 legislation and guidelines.


• Proactively identify and initiate departmental process improvements, draft and review departmental processes and SOPs for activities relevant to this position and leads special projects as assigned.


• Promote a pro-active sense of ownership through agility, accountability and entrepreneurial action and mindset.  Align with global, regional, and local regulatory objectives and execute as per plan.

Requirements

• An advanced degree in Life Sciences and/or degree in Life Sciences with relevant experience.


• Proven leadership, people development and management skills.


• More than 8 years of industry experience in a highly functioning position, conveying exposure to global 


• Regulatory Authorities and Government Agencies.


• More than 5 years of direct CMC experience in a pharmaceutical field.


• Fluent in English.


• 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


• 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.


• 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 apply learnings from previous experiences.


• 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