Specialist II, US Product CMC Regulatory Affairs (Hybrid)

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.

Support US Product CMC RA Submissions:

• 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.

CMC RA Database Maintenance, US Regulatory Intelligence Support and Medical & Technical Information support activities:

• 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.

Support Clinical Trial Compliance:

• 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).

Support NDA Compliance:

• 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.

CPD3 compliance:

Facilitate Knowledge Sharing/Management:

• Supports/maintains knowledge sharing systems within G CMC RA (e.g., REGWIKEPDIA, Knowledge page, US CMC RA Webpage, etc...).

Requirements

• 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.

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