Regulatory Associate Manager

1 month ago

Bengaluru, India GSK Full time
Nombre del sítio: Bengaluru Luxor North Tower
Fecha de publicación: Apr 30 2024

Job Purpose :

  • Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.
  • Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing Organizations and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers.
  • Will serve as a mentor/trainer for new team members.

May act as a Subject Matter Expert for specific areas for consultation within the team/ department as well as externally outside the department.

Key Responsibilities :

  • Independently and confidently executes agreed dossier strategy.
  • Independently manages multiple Rx and/or Vx project assignments simultaneously; assignments will range in complexity, but more complex work is expected.
  • Independently completes data assessment to ensure dossier is fit for purpose.
  • Identifies risks associated with submission data and information packages.
  • Escalates issues with line manager that have business impact.
  • May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes, policies and systems.
  • Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff. 
  • Understands internal/external Regulatory environment.
  • Actively builds an organisational network (PSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing.
  • Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK.

Job-Related Experience

  • Minimum 6-10 years of experience
  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
  • Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner
  • Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
  • Ability to build effective working relationships and work in a matrix environment effectively
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.

Nuestro objetivo es ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo. Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increíble. Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo.

  

Aviso importante a las empresas o agencias de empleo

GSK no acepta recomendaciones de empresas de empleo o agencias de empleo con respecto a las vacantes publicadas en este sitio. Todas las empresas o agencias de empleo están obligadas a ponerse en contacto con el Departamento de Contrataciones Comerciales y Generales o el Departamento de Recursos Humanos de GSK para obtener autorización previa por escrito antes de recomendar a cualquier candidato a GSK. La obtención de autorización previa por escrito es una condición precedente a cualquier acuerdo (verbal o escrito) entre la empresa o agencia de empleo y GSK. En ausencia de dicha autorización por escrito, se considerará que las acciones que emprenda la empresa o agencia de empleo se han realizado sin el consentimiento o el acuerdo contractual de GSK. Por lo tanto, GSK no será responsable de ninguna tarifa derivada de tales acciones o cualquier tarifa que surja de cualquier recomendación por parte de las empresas o agencias de empleo con respecto a las vacantes publicadas en este sitio.

  • Regulatory Associate

    3 days ago

    Bengaluru, India Novo Nordisk Full time

    **Department: Clinical Medical Regulatory (CMR)** Do you want to be a part of a high performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters and a genuine interest in working with people? If you find...

  • Regulatory Adherence Associate

    2 months ago

    Bengaluru, India F335 Deutsche India Private Limited, Bangalore Branch Full time

    Description The Regulatory Adherence Associate will be responsible for the governance of Regulatory Assurance and Reporting across CB, IB and CRU including supporting the delivery of risk and control initiatives and participating in risk and control activities. They will work closely with Operations across multiple products and locations to ensure the...

  • Regulatory Adherence Associate

    1 week ago

    Bengaluru, India F335 Deutsche India Private Limited, Bangalore Branch Full time

    Description The Regulatory Adherence Associate will be responsible for the governance of Regulatory Assurance and Reporting across CB, IB and CRU including supporting the delivery of risk and control initiatives and participating in risk and control activities. They will work closely with Operations across multiple products and locations to ensure the...

  • Regulatory Affairs Associate

    1 month ago

    Bengaluru, India Parexel Full time

    **Regulatory Affairs Associate** 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: - Submission delivery strategy - Review of documents - Analysis of...

  • Regulatory Associate Manager

    1 month ago

    Bengaluru, Karnataka, India GSK Full time

    Nome della sede: Bengaluru Luxor North TowerData di apertura: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Associate Manager

    1 month ago

    Bengaluru, Karnataka, India GSK Full time

    Nazwa biura: Bengaluru Luxor North TowerPosted Date: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Associate Manager

    1 month ago

    Bengaluru, Karnataka, India GSK Full time

    Nama Site: Bengaluru Luxor North TowerTanggal Posting: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Associate Manager

    1 month ago

    Bengaluru, Karnataka, India GSK Full time

    Standort: Bengaluru Luxor North TowerDatum: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing Organizations and...

  • Regulatory Associate Manager

    1 month ago

    Bengaluru, Karnataka, India GSK Full time

    İş Yeri: Bengaluru Luxor North TowerYayın tarihi: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Associate Manager

    1 month ago

    Bengaluru, Karnataka, India GSK Full time

    Nombre del sítio: Bengaluru Luxor North TowerFecha de publicación: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract...

  • Regulatory Associate Manager

    1 month ago

    Bengaluru, Karnataka, India GSK Full time

    Nome do Local: Bengaluru Luxor North TowerData da Publicação: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Associate Manager

    1 week ago

    Bengaluru, Karnataka, India GSK Full time

    Nama Site: Bengaluru Luxor North TowerTanggal Posting: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Associate Manager

    1 week ago

    Bengaluru, Karnataka, India GSK Full time

    İş Yeri: Bengaluru Luxor North TowerYayın tarihi: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Associate Manager

    1 week ago

    Bengaluru, Karnataka, India GSK Full time

    Standort: Bengaluru Luxor North TowerDatum: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing Organizations and...

  • Regulatory Associate Manager

    1 week ago

    Bengaluru, Karnataka, India GSK Full time

    Nome do Local: Bengaluru Luxor North TowerData da Publicação: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Associate Manager

    1 week ago

    Bengaluru, Karnataka, India GSK Full time

    Nombre del sítio: Bengaluru Luxor North TowerFecha de publicación: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract...

  • Regulatory Associate Manager

    1 week ago

    Bengaluru, Karnataka, India GSK Full time

    Nazwa biura: Bengaluru Luxor North TowerPosted Date: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Associate Manager

    1 week ago

    Bengaluru, Karnataka, India GSK Full time

    Nome della sede: Bengaluru Luxor North TowerData di apertura: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Associate Manager

    1 month ago

    Bengaluru, Karnataka, India GSK Full time

    Nom du site: Bengaluru Luxor North TowerData de publication: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Associate Manager

    1 week ago

    Bengaluru, Karnataka, India GSK Full time

    Nom du site: Bengaluru Luxor North TowerData de publication: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...