Global Reg Sub Publishing Associate
3 weeks ago
Job ID- 366226BR- Mar 02, 2023- India**Job Description**:
- 26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.
- We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever—OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. Read on to learn what you could do as part of our closely knit team.
- Your responsibilities include, but are not limited to:
- Responsible for electronically preparing, publishing, quality reviews, validation (using eCTD validator tool), and dispatch activities related to regulatory submissions (e.g., INDs, BLAs/NDAs, MAAs, HA AtoQs, Global Labeling, Annual Reports, etc.).
- Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS and Paper) in adherence to assigned timelines and in compliance with worldwide HA requirements (US, EU, LACan, Most of World).
- Partners with Operations Submission Managers and a publishing team located in 3 regions (e.g., US, EU and India) and actively functions in a global capacity.
- Liaises /collaborates with cross functional team members and document authors (e.g., Project Management, Clinical, Nonclinical, CMC, Safety and Quality functions) to achieve timely dispatch of high quality submissions.
- Support implementation of new technologies, tools and processes as well as contribute to ongoing initiatives and training efforts.
- Identify process or technical issues and propose solutions relating to timing, quality, compliance and resources.
- Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team.
**Diversity & Inclusion / EEO**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum Requirements**:
- 3-5 years submission publishing experience in Pharma or related industry.
- Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
- Effective interpersonal skills, strong written and oral communication and presentation skills. Project management and time management skills to manage multiple ongoing projects simultaneously.
- Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
- Working knowledge of regulatory affairs. Works independently and with mínimal supervision.
- Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly.
- Analytical skills and problem solving skills. Ability to coordinate and work effectively with cross-functional teams.
WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Division
- Global Drug Development
Business Unit
- REG AFFAIRS GDD
Location
- India
Site
- Hyderabad, AP
Company / Legal Entity
- Nov Hltcr Shared Services Ind
Functional Area
- Research & Development
Job Type
- Full Time
Employment Type
- Regular
Shift Work
- No
-
Professor / Associate Professor / Assistant
4 weeks ago
Hyderabad, Telangana, India Narsee Monjee Institute of Management Studies (NMIMS) Full timeFOR THE POST OF PROFESSOR i. Essential: a) A Ph.D. Degree with First Class Bachelor’s or Master’s Degree in Law b) A Minimum of 15 years of experience in teaching/research and / or industry at the level of Associate Professor or equivalent grade, excluding period spent on obtaining the research leading to Ph.D degree/academic administration in a...
-
Professor / Associate Professor / Assistant
4 weeks ago
Hyderabad, Telangana, India Shri Vile Parle Kelavani Mandal Full timeFOR THE POST OF PROFESSOR i. Essential: a) A Ph.D. Degree with First Class Bachelor’s or Master’s Degree in Law b) A Minimum of 15 years of experience in teaching/research and / or industry at the level of Associate Professor or equivalent grade, excluding period spent on obtaining the research leading to Ph.D degree/academic administration in a...
-
Hyderabad, Telangana, India Narsee Monjee Institute of Management Studies (NMIMS) Full time**FOR THE POST OF PROFESSOR** - Essential: A Ph.D. Degree with First Class at Bachelor’s or Master’s Degree in Finance and experience of ten years in teaching, research and / or industry at the level of Associate Professor or equivalent grade, excluding period spent on obtaining the research degree. **OR** - First Class Master’s Degree in Finance. -...
-
Professor / Associate Professor / Assistant
4 weeks ago
Hyderabad, Telangana, India Narsee Monjee Institute of Management Studies (NMIMS) Full time**Qualifying Criteria - PROFESSOR**: **AND** Minimum 10 SCI Publications in peer-reviewed or UGC-listed journals **AND** Minimum Research Score of 120 **AND** Minimum of 10-15 years of experience in teaching/research/industry, of which at least 3 years shall be equivalent to Associate Professor. OR - A Ph.D. Degree with First Class (or an equivalent...
-
Hyderabad, Telangana, India Shri Vile Parle Kelavani Mandal Full time**FOR THE POST OF PROFESSOR** - Essential: A Ph.D. Degree with First Class at Bachelor’s or Master’s Degree in Finance and experience of ten years in teaching, research and / or industry at the level of Associate Professor or equivalent grade, excluding period spent on obtaining the research degree. **OR** - First Class Master’s Degree in Finance. -...
-
Associate, Quantitative Analysis
4 weeks ago
Hyderabad, Telangana, India S&P Global Full time**About the Role**: **Grade Level (for internal use)**: 08 **Role**: Associate, Quantitative Analysis **The Team**: **Responsibilities and Impact**: Work as part of analytics team based in Bangalore/Hyderabad/Gurgaon/Ahmedabad to develop/deploy new products Support the team or management by producing quick-turnaround analysis, model development, and quality...
-
Hyderabad, India Novartis Full timeJob Summary/Purpose :The Global Associate Director, Solutions Delivery Pipeline & Portfolio Solutions reports to the Global Head, Regulatory, Patient Safety and Pipeline & Portfolio Solutions. The role is managing service delivery for a business area/sub capability of the company across all geographies. Accountable to Global Business Units for end-to-end...
-
Deep Sub Micron Analog Circuit Design Engineer
2 weeks ago
Hyderabad, India MY Search Full timeOur client is one of the fastest-growing semiconductor services company. They deliver end-to-end solutions of the best quality with the shortest development cycle to the global semiconductor industry. Our client's cutting edge solutions include : - ASIC Design - Verification - Physical Design - DFT - Circuit Design & Layout - FPGA Design and...
-
Deep Sub Micron Analog Circuit Design Engineer
3 weeks ago
Hyderabad, Telangana, India MY Search Full timeOur client is one of the fastest-growing semiconductor services company. They deliver end-to-end solutions of the best quality with the shortest development cycle to the global semiconductor industry. Our client's cutting edge solutions include : - ASIC Design - Verification - Physical Design - DFT - Circuit Design & Layout - FPGA Design and...
-
Deep Sub Micron Analog Circuit Design Engineer
2 weeks ago
Hyderabad, India MY Search Full timeOur client is one of the fastest-growing semiconductor services company. They deliver end-to-end solutions of the best quality with the shortest development cycle to the global semiconductor industry. Our client's cutting edge solutions include : - ASIC Design - Verification - Physical Design - DFT - Circuit Design & Layout - FPGA Design and...
-
Deep Sub Micron Analog Circuit Design Engineer
4 weeks ago
hyderabad, India MY Search Full timeOur client is one of the fastest-growing semiconductor services company. They deliver end-to-end solutions of the best quality with the shortest development cycle to the global semiconductor industry. Our client's cutting edge solutions include : - ASIC Design - Verification - Physical Design - DFT - Circuit Design & Layout - FPGA Design and EmulationThey...
-
Professor / Associate Professor / Assistant
4 weeks ago
Hyderabad, Telangana, India Narsee Monjee Institute of Management Studies (NMIMS) Full timeSVKM’s Narsee Monjee Institute of Management Studies (NMIMS) Deemed to be University, a trendsetter & frontrunner in professional education, invites applicants for the Faculty Positions in Management Courses. OR First Class graduate and professionally qualified Chartered Accountant / Cost and Works Accountant / Company Secretary of the concerned...
-
Associate People Partner
3 weeks ago
Hyderabad, Telangana, India Novartis Full time9000! That’s how many Novartis India associates the India People Partner team supports. We strive to ‘Unleash the power of our people’ to achieve our shared purpose of ‘Reimagining medicine’. To fulfill this purpose, we’re focused on transforming our culture and providing support and opportunity to our associates to grow and develop, so that they...
-
Global Specialist, Solutions Delivery Pipeline
4 weeks ago
hyderabad, India Novartis Full timeJob Summary/Purpose :The Global Specialist, Solutions Delivery Pipeline & Portfolio Solutions reports to the Global Head, Regulatory, Patient Safety and Pipeline & Portfolio Solutions. The role is managing service delivery for a business area/sub capability of the company across all geographies. Accountable to Global Business Units for end-to-end project...
-
Professor / Associate Professor / Assistant
4 weeks ago
Hyderabad, Telangana, India Narsee Monjee Institute of Management Studies (NMIMS) Full timeThe incumbent shall be responsible for Teaching at Graduate level in Commerce & Management along with Co-ordination, Development of respective Programme of the university. **FOR THE POST OF PROFESSOR** - Ph.D. with First Class Master’s Degree in Business Management / Administration / in a relevant management related discipline - Consistently good academic...
-
Global Specialist, Solutions Delivery Pipeline
4 weeks ago
Hyderabad, India Novartis Full timeJob Summary/Purpose :The Global Specialist, Solutions Delivery Pipeline & Portfolio Solutions reports to the Global Head, Regulatory, Patient Safety and Pipeline & Portfolio Solutions. The role is managing service delivery for a business area/sub capability of the company across all geographies. Accountable to Global Business Units for end-to-end project...
-
Associate, Global Security
3 weeks ago
hyderabad, India JPMorgan Chase & Co. Full timeJob Description The position shall be responsible for day-to-day physical security operations to include Life safety, Investigations, Incident handling, Access control, Guard force and Vendor management and Regulatory Audits. The position calls for a high degree of operations acumen with a positive attitude and inclination to identify appropriate...
-
Associate, Global Security
3 weeks ago
Hyderabad, India JPMorgan Chase & Co. Full timeJob Description The position shall be responsible for day-to-day physical security operations to include Life safety, Investigations, Incident handling, Access control, Guard force and Vendor management and Regulatory Audits. The position calls for a high degree of operations acumen with a positive attitude and inclination to identify appropriate...
-
Document Coordinator, Global Trial Acceleration
4 weeks ago
Hyderabad, Telangana, India Bristol-Myers Squibb Full time**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Sps T4 Associate
4 weeks ago
Telangana, India ADCI HYD 16 SEZ - H83 Full time1+ years of customer service experience - 1+ years of driving process improvements experience - Speak, write, and read fluently in English - Experience with Excel - Work a flexible schedule/shift/work area, including weekends, nights, and/or holidays Description The Selling Partner Support (SPS) organization in Amazon provides world-class support to our...