- 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.
- 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.
- 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.
-
Regulatory Associate Manager
1 week ago
GSK Bengaluru, India OTHERİş 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 ...
-
Regulatory Associate Manager
1 week ago
GSK Bengaluru, India OTHERNome 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 ...
-
Regulatory Associate Manager
1 week ago
GSK Bengaluru, India OTHERTên 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 ...
-
Regulatory Associate Manager
1 week ago
GSK Bengaluru, India OTHERNom 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 ...
-
Associate Manager
1 week ago
Razorpay Bengaluru, IndiaDear 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 ...
-
Associate Manager
4 days ago
PhonePe Bengaluru, IndiaJob 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 ...
-
Associate Manager
1 week ago
Netradyne Bengaluru, IndiaAbout 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 ...
-
Associate Manager
1 week ago
Navi Bengaluru, IndiaAbout 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 ...
-
Associate Manager
1 day ago
Rapido Bengaluru, IndiaAbout 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 ...
-
Associate Manager
1 day ago
Talent500 Bengaluru, IndiaMarket 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 ...
-
Associate Manager
1 day ago
Talent500 Bengaluru, IndiaMarket 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 ...
-
Associate Manager
1 day ago
Navi Bengaluru, IndiaAbout 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 ...
-
Associate Manager
1 day ago
Tata Consumer Products Bangalore Urban, IndiaThis 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 ...
-
Associate Manager
6 days ago
Tata Consumer Products Bengaluru, IndiaThis 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 ...
-
Associate Manager
1 day ago
Navi Bengaluru, IndiaAbout 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 ...
-
Associate Manager
1 day ago
Infosys Bengaluru, IndiaLocation: 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 ...
-
Associate Manager
2 days ago
Educational Initiatives Bengaluru, IndiaJob 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 ...
-
Associate Manager
1 day ago
MTC Group Bengaluru, IndiaDuties & 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 ...
-
Associate Manager
1 week ago
Indegene Bengaluru, IndiaTitle: Associate Manager - Business Solutions · Date: 10 May 2024 Location: Bangalore, KA, IN · We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth oppor ...
-
associate manager
3 days ago
Seikor Bangalore, India permanentASSOCIATE MANAGER - IM ENGINEERING & DEVELOPMENT · Location : (Bangalore, Hybrid) · Exp : 11+ yrs should you look at this role : · Salary : Industry standards · - Medical Insurance · - Term Life Insurance · - 5 day work week · - Hybrid Model · - Collaborate with onshore and of ...
Regulatory Associate Manager - Bengaluru, India - 14260 GSK India Global Services Private Limited
Description
Job Purpose :
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 :
Job-Related Experience
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.