DirectorSenior Associate Director Global Regulatory Affairs CMC
DirectorSenior Associate Director Global Regulatory Affairs CMC
Posted on :
20-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
20-01-2025
Job Description
Job Title: Director/Senior Associate Director Global Regulatory Affairs CMC
Job Location: Ridgefield CT 06877 USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
The Position
J oin 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 cuttingedge 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.
If you want to apply for the position in country the Germany please use this link:
If you want to apply for the position in US: Click "Apply now".
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 worklife 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 nonstandard 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
Requirements
Director:
Required: Minimum BS/BA Chemistry Biology Pharmaceutical Science or relevant field of study. An advanced degree is preferred.
Required: Minimum BS/BA Chemistry Biology Pharmaceutical Science or relevant field of study. An advanced degree is preferred.
This position offers a base salary typically between $135000 and $350000. 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.
Our Company
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and familyowned ever since Boehringer Ingelheim takes a longterm perspective. Now we are powered by 52000 employees globally who nurture a diverse collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation there is no limit to what we can achieve.
Why Boehringer Ingelheim
With us you can grow collaborate innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition learning and development for all employees is key because your growth is our growth.
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.
Want to learn more Visit
J oin 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 cuttingedge 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.
If you want to apply for the position in country the Germany please use this link:
If you want to apply for the position in US: Click "Apply now".
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 worklife 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 nonstandard 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 CMCregulatory aspects of Development Projects Strategic Products Established Products and Strategic Projects requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs.
- Support complex nonstandard 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 inlicensing opportunities you will support indepth evaluations by reviewing CMC documentation and participating in due diligences 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.
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.
Required: Minimum BS/BA Chemistry Biology Pharmaceutical Science or relevant field of study. An advanced degree is preferred.
- With BS/BA: Min 8years 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
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and postoffer physical (if required).
- Must be 18 years of age or older.
This position offers a base salary typically between $135000 and $350000. 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.
Our Company
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and familyowned ever since Boehringer Ingelheim takes a longterm perspective. Now we are powered by 52000 employees globally who nurture a diverse collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation there is no limit to what we can achieve.
Why Boehringer Ingelheim
With us you can grow collaborate innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition learning and development for all employees is key because your growth is our growth.
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.
Want to learn more Visit
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Employment Type
Full Time
Key Skills
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