Principal Specialist - Regulatory Affairs
This is an expert-level individual contributor role, responsible for implementing CMC development strategy for drug development projects and shape the CMC Content of regulatory filings in close collaboration with the CMC Project Manager and various CMC line functions. Acts as a subject matter expert (serves as the site point of contact/process owner) for CMC with teams for key products and complex/late stage projects. Works
cross functionally with scientific/technical experts in biologics development and with a solid knowledge of regulatory guidelines. Collaborates with CMC PM and individual line functions (Bioprocess & Pharmaceutical Development: Upstream DS, Downstream DS, DP Development; Analytical Development; Operations; Quality; Global Tech RA; CMC RA Corporate etc.). Implements CMC work-packages & documentation at each phase as appropriate that meet regulatory expectations.
Works on regulatory submissions for North America. Identifies critical CMC regulatory issues and implements resolutions in close cooperation with Global Tech RA. Brings forward CMC issues/topics to Regulatory executive. Partners with others to scientifically assess agency requirements & drives development of science based approach / line of argumentation to obtain buy-in of regulatory agencies. Collaborates with appropriate line function SMEs and CMC PM and Global Tech RA. Works on Quality Overall Summary. Coordinate critical review of required registration documentation, including INDs and BLAs and performs regulatory assessments to process changes.
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:
- CMC Expert. Leverages cross functional scientific/technical expertise in biologics development and Knowledge of regulatory guidelines to proactively drive cross functional CMC content by Coaching and mentoring across all functions
- Leads coordination and communication between departments, across functions and across BI sites.
- Plans, organizes, and implements projects within specified objectives
- Provides guidance to all GMP areas (i.e. MFG, E&T, PS, etc.) to ensure compliance with all applicable regulations and assists in resolution of issues identified.
- Ensures staff are properly trained
- Develop Key Performance Indicators for the business.
- For assigned projects prepares regulatory submissions (BLA and IND) and related maintenance documentation
(amendments, supplements, annual reports, Drug and Site Master File maintenance, etc.) for US and other Regulatory Health Authorities within defined timelines and with minimal supervision.
- Leads and manages site activities within specified objectives.
- Manage site compliance documents such as GMP certifications and site registration documents.
- Ensure regulatory submissions are prepared to meet US FDA standards and Regulatory Guidance Checklists
- Authors regulatory documents with minimal supervision and serves as in-house regulatory expert to internal and external stakeholders
- Determines regulatory strategy and filing strategy for manufacturing, facility changes and R&D activities
- Acts as regulatory liaisons and single point of contact in meetings and interact with members of the project team and subteams for assigned projects.
- Review changes (change control) to manufacturing processes and laboratory methods and specifications to ensure compliance with global regulatory agency guidelines and to maintain adequate control and flexibility for the life cycle management of the product.
- Regulatory Affairs (RA) process improvement and implementation:
- Establishes RA processes and systems according to corporate procedures and establish alignment with Biopharma network.
- Identifies barriers to successful implementation of new processes and works to resolve them.
- Pro-actively engages the site to uncover issues and concerns relating to RA, and facilitates resolution and continuous improvement.
- Pro-actively identify issues to prevent missed timelines.
- Provides guidance to MFG, E&T, QC Process Sciences and/or QA to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across RA and the business including the on-going training of junior team members. Work with other RA groups to provide support, review of data, sharing of information/scheduling.
- Independently serves as RA representative in decision making and conflict resolution with junior team members as needed in the absence of the director.
- B.S. from an accredited institution in Biology, Biochemistry, Biopharmaceuticals, or equivalent
- The Principle Specialist RA must have 8 years of practical experience with antibody manufacturing or antibody
development identifying critical CMC regulatory issues and assess agency requirements in order to recommend
regulatory strategies for assigned projects.
- Three (3) year’ experience with global regulatory filings (IND/IMPD, BLA/MAA, DMF/SMF, CMC amendments.
- Experience with coordination, preparation and submission of a variety of regulatory submissions and working closely with international CMC sub-teams and project teams.
- Experience and knowledge of rules, regulations and guidance governing drugs and biologics in all phases of
- Direct regulatory authoring/writing experience.
- Knowledge and application of FDA regulations and cGMP requirements.
- Must be able to work independently with minimal supervision.
- Strong independent judgment and decision making abilities required.
- Knowledge of relevant regulatory guidances.
- Demonstrated problem-detection and problem-resolution skills required.
- Strong conflict resolution and negotiation skills required.
- Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
- Strong Project Management experience managing cross functional teams.
- Must possess excellent verbal and written communication skills; good interpersonal skills
- Experience leading individual contributors in matrix teams to successful CMC submissions. Handle two or more projects at a time. Experience with BI RA software.
- The position requires a solid understanding of CMC regulatory affairs for highly regulated markets. In addition experience with and providing CMC regulatory guidance to cross functional matrix teams is required.
- Subject Matter Expert on CMC Regulatory Affairs.
- Highly regulated (FDA, DEA, EMEA, and EPA). Significant technical/operational risk due to increasing legal and
- Participate in BI interactions with various governmental agencies/regulators and external auditors
- Strong understanding and appreciation for regulatory requirements and compliance standards under which the Fremont site is operating.
- Coordination and communication between multiple departments, including Manufacturing, Process Science, Quality and other functional areas.
- Work is primarily directed at the site; however, may interact with colleagues at other USA and worldwide sites.
- Physical Demands / Surroundings - The duties of this position may require the incumbent to exert some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds. Work environment is dependent upon the area assigned. For example, Manufacturing Operations QA requires full gowning and gloving certification, ILP will require inspection validation requirements are met, lab-based areas will require bench training and that laboratory protocols and dress code are adhered to.
- Visual Demands - Must be able to read and see clearly. Employees assigned to ILP will be required to participate and have acceptable results from vision testing including color -blindness.
- Temperaments/Mental Requirements - Frequently required to exercise judgment and make decisions. Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct.
- Attendance / Schedule - Attendance requirements are based on BIFI general attendance policies.
- 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, longterm 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.