Current jobs related to Director, Regulatory Affairs Strategy - Plainsboro, New Jersey - Genmab

  • Director, Regulatory Affairs Strategy

    1 month ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job Title: Director, Regulatory Affairs StrategyGenmab is seeking an experienced and passionate leader to join our Global Regulatory Affairs (GRA) organization as a Director, Regulatory Affairs Strategy. In this role, you will be responsible for developing and implementing global and US regulatory strategies to advance Genmab's portfolio of development...

  • Senior Director, Regulatory Affairs Strategy

    1 month ago

    Plainsboro, New Jersey, United States Genmab Full time

    About the RoleWe are seeking an experienced and passionate leader to join our Global Regulatory Affairs (GRA) organization as a Senior Director, Regulatory Affairs Strategy. As a key member of our Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.Key...

  • Senior Director, Regulatory Affairs Strategy

    1 month ago

    Plainsboro, New Jersey, United States Genmab Full time

    About the RoleGenmab is seeking an experienced and passionate leader to join our Global Regulatory Affairs (GRA) organization. As a Senior Director, Regulatory Affairs Strategy, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.Key ResponsibilitiesAct as the US/Global Regulatory Leader (GRL)...

  • Director, Regulatory Affairs Strategy NJ

    4 weeks ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job DescriptionGenmab is seeking an experienced and passionate leader to join our Global Regulatory Affairs (GRA) organization as a Director, Regulatory Affairs Strategy NJ. In this role, you will be responsible for developing and implementing global and US regulatory strategies to advance Genmab's portfolio of development pipeline candidate drugs.Key...

  • Regulatory Affairs Director

    2 weeks ago

    Plainsboro, New Jersey, United States Firmenich Incorporated Full time

    Job SummaryFirmenich Incorporated seeks a highly skilled Regulatory Affairs Director to lead the Regulatory Affairs function with a focus on serving internal and external customers and business units, driving business impact, and contributing to value creation.Key ResponsibilitiesProvide thought leadership, strategy, and governance regarding regulatory...

  • Director, Regulatory Affairs Strategy

    1 month ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job OverviewGenmab is seeking an experienced Regulatory Affairs professional to join our Global Regulatory Affairs organization. As a key member of our team, you will be responsible for developing and implementing global and US regulatory strategies to advance our portfolio of development pipeline candidate drugs.Key Responsibilities:Develop and implement...

  • Senior Director, Regulatory Affairs Strategy

    2 months ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job DescriptionAt Genmab, we're committed to building extraordinary futures together, by developing innovative products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.We believe that being uniquely talented, determined to be our best, and authentic is essential to fulfilling our purpose.The...

  • Regulatory Affairs Director

    2 months ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job OverviewGenmab is seeking an experienced Regulatory Affairs professional to join our Global Regulatory Affairs (GRA) organization. As a key member of our team, you will be responsible for developing and implementing global and US regulatory strategies to advance our portfolio of development pipeline candidate drugs.Key Responsibilities:Develop and...

  • Senior Director, Regulatory Affairs Strategy

    1 month ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job OverviewGenmab is seeking an experienced Regulatory Affairs leader to join our Global Regulatory Affairs (GRA) organization. As a key member of our team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.Key Responsibilities:Develop and implement US and global regulatory strategies for...

  • Director, Regulatory Affairs Strategy Lead

    1 month ago

    Plainsboro, New Jersey, United States Genmab Full time

    About the RoleWe are seeking an experienced and passionate leader to join our Global Regulatory Affairs (GRA) organization at Genmab. As a key member of our team, you will be responsible for developing and implementing global and US regulatory strategies to advance our portfolio of development pipeline candidate drugs.Key ResponsibilitiesAct as the US/Global...

  • Director of Global Medical Affairs Strategy

    4 weeks ago

    Plainsboro, New Jersey, United States Genmab Full time

    About the RoleWe are seeking a highly skilled and experienced Director of Global Medical Affairs Strategy to join our team at Genmab. As a key member of our Medical Affairs Strategy Team, you will be responsible for developing and executing global medical affairs strategic and tactical plans for our assets in solid tumors and beyond.Key ResponsibilitiesLead...

  • Director of Global Medical Affairs Strategy

    4 weeks ago

    Plainsboro, New Jersey, United States Genmab Full time

    About the RoleWe are seeking a highly skilled and experienced Director of Global Medical Affairs Strategy to join our team at Genmab. As a key member of our Medical Affairs Strategy Team, you will be responsible for developing and executing the global medical affairs strategic and tactical plans for our assets.Key ResponsibilitiesLead annual medical planning...

  • Director of Global Medical Affairs Strategy

    4 weeks ago

    Plainsboro, New Jersey, United States Genmab Full time

    About the RoleWe are seeking a highly skilled and experienced Director of Global Medical Affairs Strategy to join our team at Genmab. As a key member of our Medical Affairs Strategy Team, you will be responsible for developing and executing global medical affairs strategic and tactical plans for our asset(s) in solid tumors.Key ResponsibilitiesLead annual...

  • Regulatory Affairs Director

    2 months ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job DescriptionAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.We're looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs organization....

  • Director, Global Medical Affairs Strategy and Development

    2 months ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job DescriptionAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.We're seeking a highly skilled and experienced Director, Global Medical Affairs Strategy and Development to join our...

  • Global Medical Affairs Strategy Director

    2 months ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job DescriptionAt Genmab, we're committed to building extraordinary futures together, by developing innovative products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we...

  • Director, Global Medical Affairs Strategy and Development

    2 months ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job DescriptionAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...

  • Director, Global Medical Affairs Strategy and Development

    2 months ago

    Plainsboro, New Jersey, United States Genmab Full time

    About the RoleGenmab is seeking a highly skilled and experienced Director to lead the development and execution of the Global Medical Affairs strategic and tactical plans for our robust and diverse antibody products in immuno-oncology and beyond.Key ResponsibilitiesLead annual medical planning for our assets and work closely with extended medical affairs...

  • Director, Global Medical Affairs Strategy

    1 month ago

    Plainsboro, New Jersey, United States Genmab Full time

    About the RoleWe are seeking a highly skilled and experienced Director to join our Medical Affairs team at Genmab. As a key member of our team, you will be responsible for developing and executing the global medical affairs strategic and tactical plans for our assets. Your expertise in solid tumors and ability to translate commercial and scientific goals...

  • Regulatory Affairs Leader

    4 weeks ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job Title: Regulatory Affairs LeaderGenmab is seeking an experienced Regulatory Affairs Leader to join our Global Regulatory Affairs (GRA) organization. As a key member of our team, you will be responsible for developing and implementing global and US regulatory strategies to advance our portfolio of development pipeline candidate drugs.Key...

Director, Regulatory Affairs Strategy

2 months ago

Plainsboro, New Jersey, United States Genmab Full time

About the Role

Genmab is seeking an experienced and passionate leader to join our Global Regulatory Affairs (GRA) organization. As a key member of our team, you will be responsible for developing and implementing global and US regulatory strategies to advance our portfolio of development pipeline candidate drugs.

Key Responsibilities

  • Develop and implement global and US regulatory strategies for assigned projects, ensuring compliance with regulatory requirements and company policies.
  • Represent GRA in Compound Development Teams (CDTs) to successfully meet project deliverables and regulatory requirements.
  • Lead the Global Regulatory Team (GRT) and Submission Team(s), ensuring timely and effective submission of regulatory documents.
  • Evaluate regulatory risk and recommend mitigation strategies to cross-functional teams and management.
  • Develop and review submission documentation to support successful INDs/CTAs and marketing applications.
  • Evaluate competitive landscape and regulatory mechanisms to optimize product development, presenting options and recommendations to expedite the path to market.
  • Collaborate with the Labeling team to develop the Company Core Data Sheet and US Prescribing Information.
  • Consult with senior management to develop and communicate regulatory strategies and advice for products and programs.
  • Interact with the US FDA and global health agencies, leading and/or participating in meetings as appropriate.
  • Monitor and assess regulatory guidelines, regulations, and current regulatory environment/landscape, and their impact on product development.
  • Maintain an updated knowledge of regulatory topics and regulations, participating in maintaining and preparing regulatory processes and ways of working.
  • Build strong relationships with key external stakeholders, including regulatory agencies, professional societies, and key opinion leaders.
  • Participate in review of and comment on regulatory guidance as relevant.

Requirements

  • BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred).
  • Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred).
  • Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA).
  • Solid understanding and experience in drug development, including early and late development.
  • Broad knowledge of life-cycle management.
  • Strong strategic skills, including the ability to make complex decisions.
  • Solid knowledge and understanding of global and US regulations and the US pharmaceutical market.
  • Solid knowledge and understanding of complex medical and scientific subject matter, as well as evolving regulatory policy and guidance.
  • Strong organizational, communication (both oral and written), and time management skills, needed to manage multiple ongoing projects/tasks simultaneously.
  • Must have attention to detail and be able to solve problems with minimal supervision.
  • Ability to work independently, with an ability to drive projects to successful outcomes.
  • Ability to influence others and resolve conflicts.
  • Highly motivated and self-driven individual, who enjoys being challenged.
  • Unquestionable ethics, professional integrity, and personal values consistent with the Genmab values.