Jobs
>
Bengaluru

    Regulatory Associate Manager - Bengaluru, India - GSK

    GSK
    GSK Bengaluru, India

    1 week ago

    GSK background
    OTHER
    Description
    工作地點名稱: Bengaluru Luxor North Tower
    刊登日期: 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 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.

    我們的目標是成為全世界最具創新能力、績效最佳且最值得信賴的醫療照護公司之一。我們相信我們每個人都為 GSK 帶來獨特的東西,而且當我們將我們的知識、經驗和風格結合在一起時,就會產生令人難以置信的影響力。歡迎加入我們在 GSK 的探險行列,在這裡您將會受到啟發,為我們的病患和消費者拿出您的最佳表現。在這裡您可以盡情做您自己、體驗美妙的感受,並且不斷成長。

    給職業介紹公司/介紹所的重要通知

    GSK 不接受職業介紹公司及/或職業介紹所針對本網站公佈的職缺所做的推薦。所有職業介紹公司/介紹所都必須先連絡 GSK 的商業和一般採購/人力資源部門來取得事先的書面授權,然後才可以推薦任何候選者給 GSK。取得事先的書面授權是職業介紹公司/介紹所與 GSK 之間達成任何協議 (口頭或書面) 的先決條件。如果沒有獲得此類書面授權,職業介紹公司/介紹所所採取的任何行動均應視為未經 GSK 同意或合約協議而進行。因此,關於本網站所公佈的職缺,GSK 對於職業介紹公司/介紹所因此類行為所產生的任何費用或是因任何推薦所產生的任何費用概不負責。

  • GSK

    Regulatory Associate Manager

    1 week ago

    GSK Bengaluru, India OTHER

    İş Yeri: Bengaluru Luxor North Tower · Yayın 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 ...

  • GSK

    Regulatory Associate Manager

    1 week ago

    GSK Bengaluru, India OTHER

    Nome della sede: Bengaluru Luxor North Tower · Data 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 P ...

  • GSK

    Regulatory Associate Manager

    1 week ago

    GSK Bengaluru, India OTHER

    Tên địa điểm: Bengaluru Luxor North Tower · Ngày đăng tuyển: 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 Pharm ...

  • GSK

    Regulatory Associate Manager

    1 week ago

    GSK Bengaluru, India OTHER

    Nom du site: Bengaluru Luxor North Tower · Data 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 Ph ...

  • Netradyne

    Associate Manager

    6 days ago

    Netradyne Bengaluru, India

    About Us · Netradyne, an innovator in fleet and road safety technologies, utilizes the potential of Artificial Intelligence and Edge Computing to transform the transportation ecosystem. By adopting Netradyne's vision-based technology, organizations have achieved remarkable result ...

  • Razorpay

    Associate Manager

    6 days ago

    Razorpay Bengaluru, India

    Dear All, · Razorpay, Bengaluru is hiring an Associate Manager - Enterprise Sales · The role: · The Associate Manager will hunt for new relationships and manage onboarding, implementation, training, increasing adoption across products, ensuring retention, and high levels of custo ...

  • PhonePe

    Associate Manager

    3 days ago

    PhonePe Bengaluru, India

    Job Title: Associate Manager – Ethics Investigation · Location: Bengaluru, India · PhonePe values: Integrity, Positive Disruption, Learn Fast, Fail Fast, Bias for Impact, Transparency, Collaboration, Excellence in People, Openness of Thought, Customer First, Holistic Approach, Le ...

  • Navi

    Associate Manager

    1 week ago

    Navi Bengaluru, India

    About Navi · Navi is one of the fastest-growing financial services companies in India providing Personal & Home Loans, UPI, Insurance, Mutual Funds, and Gold. Navi's mission is to deliver digital-first financial products that are simple, accessible, and affordable. Drawing on ou ...

  • Navi

    Associate Manager

    7 hours ago

    Navi Bengaluru, India

    About Navi · Navi is one of the fastest-growing financial services companies in India providing Personal & Home Loans, UPI, Insurance, Mutual Funds, and Gold. Navi's mission is to deliver digital-first financial products that are simple, accessible, and affordable. Drawing on ou ...

  • Infosys

    Associate Manager

    7 hours ago

    Infosys Bengaluru, India

    Location: Bangalore · Responsibilities: · 1) BCMS planning (organizational, locational and account level) · 2) Business Impact Analysis, Risk Assessments · 3) Coordinating with various functions/locations/accounts for BCMS · 4) Ensure standardization of BCMS arrangements throug ...

  • Educational Initiatives

    Associate Manager

    1 day ago

    Educational Initiatives Bengaluru, India

    Job Description: · 1.Support in executing the business development strategy to expand EI's reach and impact with CSO, governments and grantmakers. · 2.Cultivate and maintain strong relationships with existing partners to ensure mutual success and · continued collaboration. · 3 ...

  • Tata Consumer Products

    Associate Manager

    7 hours ago

    Tata Consumer Products Bangalore Urban, India

    This job opportunity closely aligns driving business on our eCommerce channel across multiple platforms. The eCommerce Search Specialist will be responsible for managing and optimizing discovery of our products to ensure the best possible customer experience. The ideal candidate ...

  • Navi

    Associate Manager

    7 hours ago

    Navi Bengaluru, India

    About Navi · Navi is one of the fastest-growing financial services companies in India providing Personal & Home Loans, UPI, Insurance, Mutual Funds, and Gold. Navi's mission is to deliver digital-first financial products that are simple, accessible, and affordable. Drawing on ou ...

  • MTC Group

    Associate Manager

    7 hours ago

    MTC Group Bengaluru, India

    Duties & Responsibilities - · Monthly closing & preparation of reports & analysis for the management. · Interaction with Statutory and Internal auditor for timely completion. · Preparation of tax audits details. · Preparation of fixed assets register. · Monitoring of 26AS & GST ...

  • Rapido

    Associate Manager

    7 hours ago

    Rapido Bengaluru, India

    About Rapido · We are India's largest bike-taxi platform, steadily venturing into Auto, Delivery, Rental, and more. Currently, present in ~100 cities, we are growing close to ~50% year-on-year with steady funding. We have changed the concept of intra-city travel and made last-mil ...

  • Talent500

    Associate Manager

    7 hours ago

    Talent500 Bengaluru, India

    Market Research Analyst: · Conduct research using both systematic and intuitive secondary research techniques and industry standard primary research methods. · Continuously monitor the market and provide insightful quantitative and strategic analysis to our clients through variou ...

  • Talent500

    Associate Manager

    3 hours ago

    Talent500 Bengaluru, India

    Market Research Analyst: · Conduct research using both systematic and intuitive secondary research techniques and industry standard primary research methods. · Continuously monitor the market and provide insightful quantitative and strategic analysis to our clients through variou ...

  • Tata Consumer Products

    Associate Manager

    5 days ago

    Tata Consumer Products Bengaluru, India

    This job opportunity closely aligns driving business on our eCommerce channel across multiple platforms. The eCommerce Search Specialist will be responsible for managing and optimizing discovery of our products to ensure the best possible customer experience. The ideal candidate ...

  • SLK

    Associate Manager

    2 hours ago

    SLK Bengaluru, India

    Company Name: · SLK Software Private Limited BASIC INFORMATION ON THE POSITION · Position Name: Associate Manager - Business Operations · Mandatory/Required Skills & Location · Location: · Mandatory/Required Skills: · PURPOSE OF THE ROLE · Responsible and Accountable for per ...

  • Indegene

    Associate Manager

    5 days ago

    Indegene Bengaluru, India

    Title: Associate Manager - Scientific Writing · Date: 8 Apr 2024 Location: Bangalore, KA, IN · We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportuni ...