Senior Director, Regulatory Affairs Strategy

3 weeks ago

Plainsboro, New Jersey, United States Genmab Full time
About the Role

We 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 Responsibilities
  • Develop, implement, and maintain US/global regulatory strategies across all stages of development.
  • Lead, manage, and mentor a team of regulatory professionals to ensure timely and successful submissions of drug applications to global regulatory agencies.
  • Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.
  • Provide expertise and guidance on global regulatory requirements, guidelines, and changes that may impact the company's products.
  • Prepare and review regulatory submissions, including INDs, (s)BLAs for accuracy, completeness, and compliance with regulations and guidelines.
  • Evaluate various regulatory mechanisms to optimize product development and ensure that they are implemented, if applicable.
  • Consult with senior management to develop and communicate regulatory strategies and recommendations for products and programs.
  • Interact with US FDA for assigned projects and lead/participate in meetings with FDA and other health authorities as appropriate.
  • Provide expertise and guidance on regulatory requirements, guidelines, and changes that may impact the company's products.
  • 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.
  • Drive continuous improvement initiatives to enhance regulatory processes, systems, and capabilities.
Requirements
  • BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred).
  • Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred).
  • Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA).
  • A broad knowledge of development and life-cycle management is preferred.
  • Strong strategic skills, including the ability to make complex decisions and willingness to support difficult positions.
  • Solid knowledge and understanding of global and US regulations and the US pharmaceutical commercial landscape.
  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance.
  • Direct hands-on experience with preparation and submissions of IND, (s)NDA/BLA to US FDA.
  • Experience with labeling and PMC/PMR negotiations with US FDA.
  • Ability to work well within cross-functional teams.
  • Strong communication skills – both oral and written.
  • Ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans.
  • Ability to influence others and resolve conflicts.
  • Cultural awareness and respect for diversity.
  • Unquestionable ethics, professional integrity, and personal values consistent with the Genmab values.

  • 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. This is a critical role that will play a key part in ensuring compliance with global regulations and driving the growth of our company.Key ResponsibilitiesDevelop, implement, and...

  • Senior Director, Regulatory Affairs Strategy

    3 weeks 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)...

  • Senior Director Regulatory Affairs Strategy

    3 weeks 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. In this role, you will be responsible for developing US regulatory strategies and advancing Genmab's portfolio of development and marketed drugs.Key ResponsibilitiesDevelop and implement...

  • Senior Director Regulatory Affairs Strategy

    4 weeks 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. This is a critical role that will play a key part in advancing our portfolio of development and marketed drugs.Key ResponsibilitiesDevelop and implement US/global regulatory...

  • Director, Regulatory Affairs Strategy

    2 weeks 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 NJ

    4 weeks 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 NJ. This is a critical role that will play a key part in ensuring compliance with global regulations and driving the growth of our company.Key ResponsibilitiesDevelop, implement, and...

  • Senior Director, Regulatory Affairs Strategy

    1 month 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...

  • Director, Regulatory Affairs Strategy NJ

    1 week 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...

  • Senior Director, Regulatory Affairs Strategy

    3 weeks ago

    Plainsboro, New Jersey, United States Genmab Full time

    Job OverviewGenmab is seeking an experienced Regulatory Affairs professional to lead the development of US and global regulatory strategies for our portfolio of development and marketed drugs. 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...

  • Senior Director, Regulatory Affairs Strategy

    3 weeks 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

    3 weeks 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...

  • Director, Regulatory Affairs Strategy Lead

    3 weeks 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...

  • Regulatory Affairs Director

    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 (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...

  • Regulatory Affairs Director

    1 month 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....

  • Regulatory Affairs Leader

    1 week 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 of Global Medical Affairs Strategy

    2 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

    2 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

    1 week 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...

  • Director, Global Medical Affairs Strategy and Development

    1 month 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

    1 month 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...