Associate Director, RA Global Regulatory Strategy, US

1 week ago

Hamilton, Ontario, Canada Allergan Full time

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 – 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

    1 week ago

    Hamilton, Ontario, Canada Allergan Full time

    Company DescriptionAt 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 consistently provide our customers with innovation, education, exceptional service, and a...

  • Associate Director Technical Services

    1 week ago

    Hamilton, Ontario, Canada Allergan Full time

    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...

  • Scientific Director, Clinical Scientist, Oncology Early Development

    1 week ago

    Hamilton, Ontario, Canada Allergan Full time

    Company DescriptionAbbVie'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...

  • Strategy Associate

    1 week ago

    Hamilton, Ontario, Canada Endeavour group Full time

    Company DescriptionLet's create a more sociable future togetherAt Endeavour, we're totally into what we do. With a portfolio that includes Dan Murphy's, BWS, ALH Hotels, Pinnacle Drinks and more, we love to bring people together. Together we share our passion for our products and industry; it's what inspires us to dream big, and continue to create new...

  • Director, Business Development, Global Commercial Oncology

    1 week ago

    Hamilton, Ontario, Canada Allergan Full time

    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 – immunology, oncology, neuroscience, and eye care – and products and...

  • Associate Director, USMAx Pipeline, Oncology

    3 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    AbbVie's MissionAbbVie's goal is to discover and provide groundbreaking medicines and solutions that tackle significant health issues today and meet the medical challenges of tomorrow. We aim to make a positive impact on people's lives in key therapeutic areas such as immunology, oncology, neuroscience, and eye care, as well as through our Allergan...

  • Associate Director, USMAx Pipeline, Oncology

    2 months ago

    Hamilton, Ontario, Canada Allergan Full time

    AbbVie's MissionAbbVie's goal is to discover and provide groundbreaking medicines and solutions that tackle significant health issues today and meet the medical challenges of tomorrow. We aim to make a positive impact on people's lives in key therapeutic areas such as immunology, oncology, neuroscience, and eye care, as well as through our Allergan...

  • Chief Medical Director

    1 week ago

    Hamilton, Ontario, Canada Allergan Full time

    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...

  • Marketing Director

    1 month ago

    Hamilton, Ontario, Canada Allergan Full time

    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 - immunology, oncology, neuroscience, and eye care - and products and services...

  • Assistant (or Associate) Medical Director, Oncology Japan Development

    3 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    Assistant (or Associate) Medical Director, Oncology Japan Development AbbVie is committed to discovering and delivering innovative medicines to address serious health issues both now and in the future. Our goal is to make a significant impact on people's lives in various essential therapeutic areas, including immunology, oncology, neuroscience, and eye care,...

  • Assistant (or Associate) Medical Director, Oncology Japan Development

    1 month ago

    Hamilton, Ontario, Canada Allergan Full time

    Assistant (or Associate) Medical Director, Oncology Japan Development AbbVie is committed to discovering and delivering innovative medicines to address serious health issues both now and in the future. Our goal is to make a significant impact on people's lives in various essential therapeutic areas, including immunology, oncology, neuroscience, and eye care,...

  • QA - Data Reviewer, Associate

    1 week ago

    Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time

    AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients' lives by advancing high quality drugs for the treatment and diagnosis of diseases.We are a community that challenges ourselves professionally, takes pride in what we can...

  • Validation Manager

    1 week ago

    Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time

    AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.About the RoleThe Quality Assurance Manager (Validation) oversees compliance with Good...

  • Vp, Supply Chain Logistics

    1 week ago

    Hamilton, Ontario, Canada Fusion Pharmaceuticals US Inc Full time

    Fusion Pharmaceuticals (NASDAQ:FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors.Fusion's clinical portfolio includes: FPI-2265 targeting...

  • Executive Medical Director Neuroscience Clinical Development

    1 week ago

    Hamilton, Ontario, Canada Allergan Full time

    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 – immunology, oncology, neuroscience, and eye care – and products and...

  • Director, Medical Data

    1 week ago

    Hamilton, Ontario, Canada BGC Hamilton-Halton Full time $85,000

    A leading provider of quality programs for children and youth, offering experiences that are affordable and accessible with a focus on learning and skill development.A dynamic individual to lead our fund development team. An experienced and successful fundraising professional, with knowledge of the non-profit sector and a passion for helping kids. A person...

  • SMA (Study Management Associate) III

    1 week ago

    Hamilton, Ontario, Canada Allergan Full time

    企業概要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...

  • Associate Business Systems Consultant, Global Trade and Compliance

    1 week ago

    Hamilton, Ontario, Canada Allergan Full time

    Associate Business Systems Consultant, Global Trade and Compliance __jobinformationwidget.freetext.LocationText__ 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...

  • Associate Director, Project Engineering

    1 week ago

    Hamilton, Ontario, Canada Allergan Full time

    __jobinformationwidget.freetext.LocationText__ North Chicago, IL Function: Operations Area of Interest: Supply Chain Management 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...

  • Director, US Oncology Finance

    1 week ago

    Hamilton, Ontario, Canada Allergan Full time

    Company DescriptionAbbVie'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...