BioCT Innovation Commons
Director/Senior Associate Director, Global Regulatory Affairs CMC
BioCT Innovation Commons, Groton, Connecticut, us, 06349
The Position
Join the Boehringer Ingelheim team and make a difference in the world of pharmaceuticals! Are you passionate about advancing healthcare and making a positive impact on patients' lives? Boehringer Ingelheim is seeking a dedicated and innovative Director/Senior Associate Director, Global Regulatory Affairs CMC for Chemical products to join our dynamic team. As a global leader in the pharmaceutical industry, we offer unparalleled opportunities for collaboration, growth, and international exposure. In this role, you will play a crucial part in the development and delivery of our cutting-edge Chemical products while also contributing to the continuous improvement of processes and standards within Regulatory Affairs. If you have a strong background in small molecules including various dosage forms and a desire to work with a diverse team of professionals, we invite you to explore this exciting opportunity at Boehringer Ingelheim. This position can be filled in different countries. 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 GRL CMC Director or Senior Associate Director has responsibility for the strategic global CMC RA management of assigned products and projects during lifecycle from development throughout marketing. The GRL CMC Director or Senior Associate Director supports complex, non-standard projects of high business impact with multiple indications and/or formulations with potential involvement of licensing partners. The incumbent will represent the function as an expert for regulatory topics within BI, monitoring developments in the assigned area of strategic importance, assessing impacts to the company and informing colleagues within RA and affected external stakeholder functions. The incumbent is responsible to identify topics for escalation to as appropriate for discussion/resolution at management forums. Duties & Responsibilities
Have worldwide responsibility for CMC-regulatory aspects of Development Projects, Strategic Products, Established Products, and Strategic Projects requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs. Support complex, non-standard projects with multiple indications and/or formulations, potentially involving licensing partners. Serve as the expert for regulatory topics within BI, monitoring developments in your assigned area of strategic importance, assessing impacts on BI, and informing colleagues in RA and affected functions. You will represent the department in international cross-functional project teams, proactively define global regulatory submission strategy for the development of our new chemical entities and provide regulatory advice regarding global CMC regulatory requirements to achieve development objectives. For in-licensing opportunities you will support in-depth evaluations by reviewing CMC documentation and participating in due diligence providing your CMC regulatory assessment. Share best practices and grow your colleagues via knowledge management training and advice. You will plan, define, review, manage and compile global Module 3 documentation for INDs / Clinical Trial Applications and Biologics License Applications / Marketing Authorization Applications. Furthermore, you will maintain current knowledge and expertise within the global CMC regulatory environment (ICH, FDA, EMA, PMDA, China and Emerging Markets). Requirements
Director: Required: Minimum BS/BA Chemistry, Biology, Pharmaceutical Science or relevant field of study. An advanced degree is preferred. With BS/BA: Min ten (10) years’ regulatory work experience in pharma industry, FDA, or equivalent experience required. With M.S.: Min eight (8) years’ work experience in pharma industry, health authorities or equivalent experience required. With Ph.D.: Min six (6) 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. Profound communication and negotiation skills, Exceptional skill in planning, organizing, decision making and problem solving, Profound interpersonal and management skills. Senior Associate Director: Required: Minimum BS/BA Chemistry, Biology, Pharmaceutical Science or relevant field of study. An advanced degree is preferred. With BS/BA: Min 8 years regulatory work experience in pharma industry, health authorities, or equivalent experience required. With M.S.: Min 6 years work experience in pharma industry, health authorities or equivalent experience required. With Ph.D.: Min 4 years work experience in pharma industry, health authorities, or equivalent experience required. 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 $135,000 and $350,000. 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.
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Join the Boehringer Ingelheim team and make a difference in the world of pharmaceuticals! Are you passionate about advancing healthcare and making a positive impact on patients' lives? Boehringer Ingelheim is seeking a dedicated and innovative Director/Senior Associate Director, Global Regulatory Affairs CMC for Chemical products to join our dynamic team. As a global leader in the pharmaceutical industry, we offer unparalleled opportunities for collaboration, growth, and international exposure. In this role, you will play a crucial part in the development and delivery of our cutting-edge Chemical products while also contributing to the continuous improvement of processes and standards within Regulatory Affairs. If you have a strong background in small molecules including various dosage forms and a desire to work with a diverse team of professionals, we invite you to explore this exciting opportunity at Boehringer Ingelheim. This position can be filled in different countries. 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 GRL CMC Director or Senior Associate Director has responsibility for the strategic global CMC RA management of assigned products and projects during lifecycle from development throughout marketing. The GRL CMC Director or Senior Associate Director supports complex, non-standard projects of high business impact with multiple indications and/or formulations with potential involvement of licensing partners. The incumbent will represent the function as an expert for regulatory topics within BI, monitoring developments in the assigned area of strategic importance, assessing impacts to the company and informing colleagues within RA and affected external stakeholder functions. The incumbent is responsible to identify topics for escalation to as appropriate for discussion/resolution at management forums. Duties & Responsibilities
Have worldwide responsibility for CMC-regulatory aspects of Development Projects, Strategic Products, Established Products, and Strategic Projects requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs. Support complex, non-standard projects with multiple indications and/or formulations, potentially involving licensing partners. Serve as the expert for regulatory topics within BI, monitoring developments in your assigned area of strategic importance, assessing impacts on BI, and informing colleagues in RA and affected functions. You will represent the department in international cross-functional project teams, proactively define global regulatory submission strategy for the development of our new chemical entities and provide regulatory advice regarding global CMC regulatory requirements to achieve development objectives. For in-licensing opportunities you will support in-depth evaluations by reviewing CMC documentation and participating in due diligence providing your CMC regulatory assessment. Share best practices and grow your colleagues via knowledge management training and advice. You will plan, define, review, manage and compile global Module 3 documentation for INDs / Clinical Trial Applications and Biologics License Applications / Marketing Authorization Applications. Furthermore, you will maintain current knowledge and expertise within the global CMC regulatory environment (ICH, FDA, EMA, PMDA, China and Emerging Markets). Requirements
Director: Required: Minimum BS/BA Chemistry, Biology, Pharmaceutical Science or relevant field of study. An advanced degree is preferred. With BS/BA: Min ten (10) years’ regulatory work experience in pharma industry, FDA, or equivalent experience required. With M.S.: Min eight (8) years’ work experience in pharma industry, health authorities or equivalent experience required. With Ph.D.: Min six (6) 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. Profound communication and negotiation skills, Exceptional skill in planning, organizing, decision making and problem solving, Profound interpersonal and management skills. Senior Associate Director: Required: Minimum BS/BA Chemistry, Biology, Pharmaceutical Science or relevant field of study. An advanced degree is preferred. With BS/BA: Min 8 years regulatory work experience in pharma industry, health authorities, or equivalent experience required. With M.S.: Min 6 years work experience in pharma industry, health authorities or equivalent experience required. With Ph.D.: Min 4 years work experience in pharma industry, health authorities, or equivalent experience required. 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 $135,000 and $350,000. 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.
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