Senior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBE

Senior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBE

Description

Are you ready to take on a pivotal role with worldwide responsibility for CMC-regulatory aspects across strategic approved products, development projects and high-impact strategic projects? Within our Global CMC Regulatory Affairs Group, we are looking for an expert to lead initiatives that demand extraordinary regulatory expertise and strategic vision.
In this role, you will support complex, non-standard projects involving multiple indications and formulations, often in collaboration with licensing partners. As a trusted expert, you will monitor developments in strategically important areas, assess their impact on Boehringer Ingelheim, and provide critical insights to colleagues in Regulatory Affairs and other key functions.
This is your opportunity to shape the future of regulatory excellence at BI while driving innovation and ensuring compliance in a dynamic, global environment. Are you ready to make a difference?
Take the next step in your career and help us shape the future of data governance!

Duties & Responsibilities

• Represents the global CMC regulatory affairs function in support of development projects; including accelerated development scenarios.
• Provides the worldwide consolidated opinion and advice on CMC regulatory requirements and topics (including review of CMC documents), during the development from Start of Development until registration.
• Establishes, maintains, and enhances CMC regulatory expertise via knowledge management, training, monitoring of regulatory trends, etc.
• Possesses and maintains knowledge of ICH, FDA, EU, JP and CN guidelines, as well as and emerging markets, and monitors and understands upcoming regulatory trends.
• Analyzes regulatory guidance and identifying identifies the relevance and impact to the Company’s development projects/ registered products.
• Reviews, coordinates and comments on proposed CMC related guidelines including regulatory initiatives/actions from ICH, FDA, EMA and other countries as appropriate.
• Enhances regulatory CMC expertise and awareness through the creation, storage and sharing of CMC RA knowledge both within Global CMC RA and with relevant external stakeholders.
• Represents Global CMC RA in relevant BI internal project teams and external project teams where regulatory CMC topics both for development and product life cycle management are concerned.
• Serves as deputy to Head of Global CMC RA for corporate Change Control matters.
• Ensures that CMC regulatory requirements for variations are available in the change management system (Global Variation Database) and supports the CMC Change Coordinator in providing worldwide regulatory assessment of change applications, the Global Variation Database coordinator is responsible for the maintenance of the database.
• Collaborates with the GRA responsible for Training & Compliance and provide CMC relevant input regarding the assignment of procedures within the department.
• Represents the worldwide CMC regulatory affairs function in support of lifecycle management activities for non-standard international products with high complexity and high business impact, e.g., drug-device combinations, formulation changes and transfers.
• Provides worldwide consolidated CMC regulatory strategy (including review of documentation) and ensures that global CMC regulatory requirements are met during the product life cycle of internationally registered products.

Requirements

• Required: Minimum BS/BA Chemistry, Biology, Pharmaceutical Science or relevant field of study. An advanced degree is preferred.
• With BS/BA: Min eight (8) years regulatory work experience in pharma industry, health authorities, or equivalent experience required.
• With M.S.: Min six (6) years’ work experience in pharma industry, health authorities or equivalent experience required.
• With Ph.D.: Min four (4) years’ work experience in pharma industry, health authorities, or equivalent experience required.
• Work experience in NCE/NBE CMC related Development, and/or Pharmaceutical Production, and/or QA/QC.
• Strong communication and negotiation skills, planning, organizing, decision making and problem solving, interpersonal and management skills.
• Ability to think strategically and transfer new ideas, concepts and new regulatory requirements or trends into operational reality.
• Demonstrated ability to lead and motivate people.
• Demonstrated understanding of the regulatory process and technical competence in core areas of drug development and can analyze and interpret complex scientific data and regulatory guidelines.
• Critical thinker with ability to work autonomously, while ensuring management remains fully informed.
• Demonstrated competence in self-directing workload, including prioritization, delegation, and delivering under tight timelines.
• Fluency with necessary computer software (MSWord, Excel, Project, etc.) and willingness to embrace further opportunities presented by emerging technological advances.

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.

Compensation

This position offers a base salary typically between $170,000 and $269,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.

This position can be filled in Ingelheim or Biberach, Germany.