Associate Director, RA Global Regulatory Strategy, US - Lincoln, United States - Allergan

Allergan Lincoln, United States

3 weeks ago

Description

Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology)

__jobinformationwidget.freetext.
LocationText__
North Chicago, IL

Function:
Research & Development

Area of Interest:
Regulatory Operations, Policy & Intelligence

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description

The Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.

This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

This individual assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs.

Responsibilities:

This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director), in the development & execution of the regulatory strategy.

Area of responsibility has significant regulatory impact and possibly significant impact to ABBV overall.
Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.

May also serves as primary liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.

Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.

Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
Operates independently, with recognition of when to consult management.
Makes decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction.
Assists in the development, training, and mentoring of staff members.

Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.

Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.

Demonstrates solid understanding of current US and Canada regulations and guidance, political and legal climate, and industry practices to assist in meeting organizational goals.

Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas and is generally recognized as a resource & leads the department as a subject matter expert (SME) for Regulatory.

Presents pertinent regulatory information to appropriate cross-functional areas.

Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Significant Work Activities -Keyboard use (greater or equal to 50% of the workday)
Qualifications

Required Education:
Bachelor's Degree (pharmacy, biology, pharmacology) or related life sciences.

Preferred Education:
Relevant advanced degree is preferred. Certification a plus.
Required Experience: 8 years Regulatory, R&D or Industry-related experience.
Preferred Experience: 5 years in pharmaceutical regulatory affairs.
Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
Extensive experience interfacing with government Agencies and Health Authority personnel.
Able to deliver challenging messages effectively without compromising important business relationships.
Experience working in a complex and matrix environment.
Demonstrated success in negotiation skills, strategic thinking, and credibility within the organization.
Strong communication skills, both oral and written.
Proven skill at implementing successful US and Canada regulatory strategies; global regulatory experience is a plus.
Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.

It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

#J-18808-Ljbffr

Senior Manager, Global Regulatory Strategy

3 weeks ago

Allergan Lincoln, United States

Company Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consist ...
Associate Director, RA Global Regulatory Strategy, US

3 weeks ago

Allergan Lincoln, United States

Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) · Function: Research & Development · Area of Interest: Regulatory Operations, Policy & Intelligence · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious healt ...
Director of Finance

2 weeks ago

Sun City Lincoln Hills Community Assoc. Lincoln, United States

**Job description** · The Director of Finance is responsible for the financial health of the Association, including the development of a financial strategy, metrics tied to that strategy, and the ongoing development and monitoring of control systems designed to preserve company a ...
Property Manager

2 weeks ago

toll gate realty Lincoln, United States

**Key Responsibilities**: · **Tenant Relations**:Handle tenant inquiries, complaints, and issues promptly and professionally. · Screen and select tenants, ensuring they meet leasing requirements and conducting background checks when necessary. · Prepare and enforce leases, collec ...
Drinking Water Process Engineer

2 weeks ago

Harrison Consulting Solutions Lincoln, United States

Multi-state design firm is seeking a Drinking Water Process Engineer for their team in Lincoln, Nebraska · Responsibilities: · Develop business development strategy and identify market trends to capture drinking water projects · Work with multi-disciplinary teams to successfully ...
Family Support Specialist

3 days ago

Bethany Christian Services Lincoln, United States

**Family Support Specialist** · **Requisition #**: req13125 · **Location**:Lincoln, RI · **Hours**:Full-time (40 hours/weekly) · **_ This position includes a one time $1,500 Sign-On Bonus_** · Bethany is changing the world through family. We began our work by serving one child mo ...
Associate Financial Advisor

1 week ago

Edward Jones Lincoln, United States

Client advocate. Skilled communicator. Problem solver. Does that describe you? If so, we need you on our team. · At Edward Jones, we're all about making a difference. In the lives of our clients - and our people. Our licensed branch associates are highly visible members of the cl ...
Director, Global Regulatory Lead

1 week ago

Allergan Lincoln, United States

Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
Manager Regulatory Affairs, In Vitro Diagnostics and Companion Diagnostics

2 weeks ago

Allergan Lincoln, United States

Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
Regulatory Affairs Manager

3 weeks ago

Allergan Lincoln, United States

__jobinformationwidget.freetext.LocationText__ · Function: Commercial · Area of Interest: Administrative Services · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow ...
Associate Director, Global Regulatory Project Management and Strategic Planning

5 days ago

Takeda Pharmaceuticals Lincoln, United States

Takeda Pharmaceuticals · Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience · Lincoln , · Nebraska · Apply Now · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that ...
Director, CMC Product Development

3 weeks ago

Allergan Lincoln, United States

Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
Director, CMC Product Development

1 week ago

Allergan Lincoln, United States

Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
Medical Director, Medical Affairs- Dermatology

3 weeks ago

Allergan Lincoln, United States

Medical Director, Medical Affairs- Dermatology · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across s ...
Senior Regulatory Affairs Specialist

3 weeks ago

J&J Family of Companies Lincoln, United States

Location field must contain 'city, state' or a zip code to perform a radius search (e.g., · Denver, CO · or · City and state must be separated by a comma followed by a space (e.g., · Houston, TX ) · J&J Family of Companies · Senior Regulatory Affairs Specialist · in · Linc ...
Director, Clinical Site

1 day ago

Velocity Clinical Research, Inc. Lincoln, Nebraska, United States Permanent

Overview: · Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of deliv ...
Regulatory Affairs Manager

3 weeks ago

Allergan Lincoln, United States

Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
Associate Director, Epidemiology JAPAC

1 week ago

Allergan Lincoln, United States

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncolog ...
President, St. Elizabeth Hospital

1 week ago

Common Spirit Lincoln, United States

Overview · CommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U.S. from clinics and hospitals to home-based care and virtual care services CommonSpirit is accessible to nearly one out o ...
President, St. Elizabeth Hospital

1 week ago

CommonSpirit Health LINCOLN, United States

CommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U.S. from clinics and hospitals to home-based care and virtual care services CommonSpirit is accessible to nearly one out of every fou ...