What are the responsibilities and job description for the Specialist II, US Product CMC Regulatory Affairs (Hybrid) position at Boehringer Ingelheim?
Description
This is a Hybrid position, requiring the individual to work on-site at our Ridgefield, CT office 2-3 days each week. Preference will be given to candidates who are either local or can commute to our Ridgefield, CT office.
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 Specialist II, US Product CMC Regulatory Affairs supports the US Products CMC RA organization. This role provides operational and logistical support for various tasks and responsibilities performed in the context of regulatory submissions and maintenance, change management activities, and compliance related tasks.
Duties & Responsibilities
Regulatory Lifecycle Management:
This position offers a base salary typically between $75,000 and $122,000. 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.
Our Company
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,000 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 https://www.boehringer-ingelheim.com
This is a Hybrid position, requiring the individual to work on-site at our Ridgefield, CT office 2-3 days each week. Preference will be given to candidates who are either local or can commute to our Ridgefield, CT office.
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 Specialist II, US Product CMC Regulatory Affairs supports the US Products CMC RA organization. This role provides operational and logistical support for various tasks and responsibilities performed in the context of regulatory submissions and maintenance, change management activities, and compliance related tasks.
Duties & Responsibilities
Regulatory Lifecycle Management:
- Supports LRL CMC RA in maintaining submissions histories for INDs/NDAs for standard drug products
- Processes dispatches of corporate and local change controls relevant to US INDs/NDAs for standard drug products
- Supports preparation of submissions utilizing available regulatory requirement standards (e.g., Region Specific CTA Matrix Database, or Requirebase as appropriate, US FDA guidance and regulation) for IND's/NDA's for standard drug products
- Supports required compliance submissions to US INDs, DMFs, NDAs for standard drug products
- Serves as the US entry point and expert for the Health Authority feedback database
- Supports senior US CMC RA staff in maintenance activities related to the Global Variations Database.
- Supports the functioning of the US RIN team and GMD Coordinator
- Supports CMC RA staff in liaising with and responding to Medical & Technical Information requests associated with BIPI Marketed Products
- Coordinates IIS study drug release with outside vendors
- Contributes to database maintenance activities for clinical trials to ensure information is current and correct (e.g., IND/IMPD Comparative Tables, GMP Tables outlining cGMP certificates and Manufacturing Authorizations/Permits)
- Tracks and maintains the CMC Establishment information required for inclusion in FDA submission application forms
- Maintains DMF LOA data and ensure that Letters of Authorization for DMFs are accurately reflected in NDAs and tracked accordingly
- Ensures CPD-3 database accurately reflects the approved/dispatched CMC information
- Supports/maintains knowledge sharing systems within G CMC RA (e.g., REGWIKEPDIA, Knowledge page, US CMC RA Webpage, etc...)
- Required: AD/BS/BA Chemistry, Biology, Pharmaceutical Science or relevant field of study preferred
- Excellent communication (verbal and written) skills
- Excellent skills in planning and organizing
- Excellent computer and information technology skills
- Ability to work in an independent, self-directed manner
- Ability to work well under pressure, work in a team environment, flexibility to adapt in a changing environment
- Detail oriented, well organized
- 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
This position offers a base salary typically between $75,000 and $122,000. 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.
Our Company
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,000 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 https://www.boehringer-ingelheim.com
Salary : $75,000 - $122,000
