Job Details
Qualifications
- Bachelor of Science
- Bachelor's degree
- Communication skills
- Doctoral degree
- FDA regulations
- Federal Aviation Regulations
- Leadership
- Management
- Master of Science
- Master's degree
Job Description
Description:
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 several 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.
The Senior Associate Director/Director, Marketed Biologics Regulatory Affairs is responsible for the direction, coordination and execution of all regulatory activities required of a BLA Holder for compliance to FDA requirements for U.S. market products in BIPI's biologics portfolio. These responsibilities include management of CMC and product labeling as well as the preparation and submission of supplemental applications and post marketing reports per US regulations. This position provides expert CMC regulatory direction for the US marketed biologic portfolio (including ATMP) with respect to the creation of CMC regulatory strategies and submissions for US regulatory applications, ensuring that the latest requirements, standards and trends are met, to maintain market approval for products in line with business objectives.
This position represents a high level of expertise in all aspects of biologics CMC regulatory affairs and biosimilars from a CMC perspective. The incumbent works in collaboration with global biologics CMC experts for a global integrated approach to US marketed products. The Director position is expected to support projects of highest regulatory complexity and business impact. In addition, this role assumes a leadership position for regulatory topics within BI, monitoring developments in the regulatory landscape, assessing impacts on the organization and informing colleagues and affected functions as appropriate. Responsible contact for US regulatory relevant topics, and primary liaison to FDA for U.S. marketed biologic product interactions. This role is also expected to be a mentor for more junior group members with limited biologics experience and may have direct reports.
Director, Marketed Biologics Regulatory Affairs
Duties & Responsibilities\:
CMC Lifecycle Management\:
Effects timely and appropriate regulatory change management of CMC changes of the highest complexity and/or business impact, in accord with the Corporate Change Management Procedures.
Supports Local Change Review Committees at manufacturing sites in their evaluation of the regulatory impact of a CMC change.
Evaluates regulatory impact of CMC changes on US BLA.
Defines CMC documents needed to support the change.
Contributes to maintenance of BI’s databases on post approval requirements, e.g., Variations database, for US requirements.
Labeling\:
As member of Product Labeling Review Team (PLRT) and in collaboration with US RA Labeling Content, provides regulatory leadership during Annual, CCDS, or ad-hoc product labeling reviews.
Collaborates with US RA Labeling Content and Labeling Operations to support submission of labeling supplements and implementation of changes to labeling.
Provides input on Country-of-Origin markings as needed.
sBLA Submissions\:
Reviews, and approves regulatory documents for submission, constructs in eCTD format, and files supplemental BLA (sBLA) submissions for CMC and/or labeling changes, including those of the highest complexity and/or business impact, and support their approval by FDA.
Ensures CPD-3 database accurately reflects the approved CMC information.
Manages the negotiation of labelling changes with FDA as needed.
Provides regulatory oversight of BI’s biologics DMFs, as US Agent or via management of MPRA staff acting as US Agent.
BLA Post Marketing Reports\:
BLA Annual Report\: Manages the preparation and final content and submission of the NDA Annual Report, each year within 60 days of the anniversary date of U.S. approval of the BLA application.
Responsible for Periodic Adverse Experience Reports (e.g., PADER, PBRER); Manages the preparation and submission and contribute to content.
BPDR - Biological Product Deviation report\: Contributes to assessment of potential quality defects, technical product complaints and/or patient complaints and participate in internal committees for decision making on BPDRs, potential market impact and communication to FDA as appropriate.
FDA Liaison\:
Primary liaison and lead regulatory contributor in FDA meetings.
Prepares cross-functional teams for FDA interactions on regulatory issues and provides guidance on preparation of briefing packages.
Regulatory Intelligence / Compendial Affairs\:
Leverages biologics CMC and regulatory experience to proactively evaluate US regulations, guidance, evolving regulatory trends and compendial updates to assess regulatory and business impact to the marketed biologics products portfolio.
Supervises, coaches, and develops the skills of MPRA staff\:
Provides regular coaching and support in keeping with the development level and needs of the employees for biologic products.
Ensures work performed by employees is high quality and meets the required timelines, aligned with goals of the group and overall DRA department.
Regulatory Professionalism\:
As a leader and change champion in CMC RA/MPRA, Proactively evaluates US regulations, guidance, evolving regulatory trends and compendial updates to assess regulatory and business impact as it pertains to BI's portfolio of products.
Disseminates regulatory expertise and insights throughout the organization as appropriate.
Requirements\:
Minimum BS/BA Chemistry, Biology, Pharmaceutical Science or relevant field of study required. An advanced degree is preferred.
With BS/BA\: Min ten (10) years regulatory experience or other relevant biologics experience within pharma.
With M.S.\: Min eight (8) years regulatory experience or other relevant biologics experience within pharma.
With Ph.D.\: Min six (6) years regulatory experience or other relevant biologics experience within pharma.
Excellent communication (verbal, written and presentation) skill.
Expert knowledge of current and evolving biologics and biosimilar CMC regulations.
Record of success with biologics CMC regulatory strategies and submissions.
Excellent interpersonal and management skills.
Willing to travel, both domestic and internationally up to ten percent of the time.
Computer and information technology literacy.
Strategic and Innovative thinker with ability to manage workload including effective prioritization and delegation.
Ability to work well under pressure, influence without decision-making authority, work in a team environment, flexibility to adapt in a changing environment.
Proven Leadership competencies and motivational skills.
Senior Associate Director, Marketed Biologics Regulatory Affairs
Duties & Responsibilities\:
Supervise, coach, and develop the skills of EPRA staff who report directly to this position. Assign /monitor work of subordinates to ensure quality, consistency, and timeliness of work. Provides NDA/DMF Submission oversight for established products.
CMC Lifecycle Management\: Effect timely and appropriate regulatory change management of CMC changes of high complexity and/or business impact, in accord with the Corporate Change Management Procedures. Support Local Change Review Committees at manufacturing sites in their evaluation of the impact of a CMC change. Evaluate regulatory impact of CMC changes on US NDA. Define CMC documents needed to support the change. Contribute to maintenance of BI’s databases on post-approval requirements (e.g., Variations database) for US requirements.
Labeling\: As member of Product Labeling Review Team (PLRT) and in collaboration with US RA Labeling Content, provide regulatory leadership during Annual, CCDS, or ad-hoc product labeling reviews.
Collaborate with US RA Labeling Content and Labeling Operations to support submission of labeling supplements and implementation of changes to labeling. Provide input on Country of Origin markings as needed.
sNDA Submissions\: Review, and approve regulatory documents for submission, construct in eCTD format, and file supplemental NDA (sNDA) submissions for CMC and/or labeling changes, including those of high complexity and/or business impact, and support their approval by FDA. Manage the negotiation of labeling changes with FDA as needed. Ensure CPD-3 database accurately reflects the approved CMC information. Where applicable, act as US Agent for BI’s Type 2 DMFs for APIs incorporated into established products; prepare and submit DMF amendments and the DMF Annual Report on behalf of the DMF Holder.
NDA Post Marketing Reports\:
NDA Annual Report\: Manage the preparation and final content and submission of the NDA Annual Report, each year within 60 days of the anniversary date of U.S. approval of the NDA application.
Periodic Adverse Experience Reports (e.g. PADER, PBRER); Manage the preparation and submission and contribute to content.
NDA – Field Alert Report\: Contribute to assessment of potential quality defects, technical product complaints and/or patient complaints and represent CMC RA in internal committees for decision making on FARs, potential market impact and communication to FDA as appropriate.
FDA Liaison\: Primary liaison with FDA in written communication and participant in FDA meetings on regulatory issues. Prepare cross-functional teams for FDA interactions on regulatory issues and provide guidance on preparation of briefing packages.
Regulatory Intelligence / Compendial Affairs\: Proactively evaluate US regulations, guidances, evolving regulatory trends and compendial updates to assess regulatory and business impact to the established products portfolio.
Regulatory Professionalism\: As a senior regulatory professional in CMC RA/EPRA, interact effectively, providing regulatory expertise to all levels of the organization.
Requirements\:
Minimum BS/BA Chemistry, Biology, Pharmaceutical Science or relevant field of study from an accredited institution.
An advanced degree is preferred.
With BS/BA\: Minimum of eight (8) years of regulatory work experience in pharma industry, FDA, or equivalent experience required.
With M.S.\: Minimum of six (6) years of work experience in pharma industry, FDA, or equivalent experience required.
With Ph.D.\: Minimum of four (4) years of work experience in pharma industry, FDA, or equivalent experience required.
Minimum five (5) years of experience providing direct regulatory support for US NDA marketed products preferred, including experience leading projects/teams/people.
Extensive knowledge of US regulatory CMC & Labeling requirements and the ability to apply knowledge both strategically and operationally to established marketed product regulatory issues.
Excellent communication (verbal, written and presentation) skills.
Excellent skills in planning, organizing, decision-making and problem-solving.
Excellent interpersonal and management skills.
Willing to travel, both domestic and internationally up to ten percent of the time.
Computer and information technology literacy.
Strategic and Innovative thinker with ability to manage workload including effective prioritization and delegation.
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.”
Leadership competencies and motivational skills.
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.