Senior Analyst in Regulatory Affairs at Novo Nordisk @Apply Now

Post : Senior Analyst - Regulatory Affairs

The position  As Regulatory Affairs (RA) Senior Analyst, you will be responsible for compiling and publishing the submission of Marketing Authorisation Application (MAA)/life cycle management application to European Health Authorities. Your key responsibilities are facilitation of submission planning meetings with RA colleagues from Product portfolio as well as submission management coordinator from Regulatory Affairs at Headquarters (RAHQ) Denmark, compilation of dossier based on Table of Contents (TOCs) provided by RA HQ and Affiliates in Electronic Common Technical Document (eCTD) format, publishing the dossier & perform post publishing activities, add navigation elements like hyperlinks, bookmarks, perform validation of submission and upload submission in European Medicines Agency (EMA) Gateway.

You will be delivering high quality registration dossiers, which require a good understanding of regulatory guidelines, administrative, chemistry, manufacturing and control (CMC), non-clinical & clinical documentation, different registration file formats (centralised procedure, mutual recognition procedure, decentralised procedure & national procedure for European Union (EU)) and the regulatory dossier publishing process. Hands on experience in publishing tools like Lorenz Docubridge, Liquent Insight, ISI Publishing, ISI Tool Box, Adobe Acrobat, etc. Hands on experience in validation tool like EURS, Lorenz, etc. Experience in xml editing & Document Management system is preferable. Exposure to e-submission gateways are mandatory. 

The job involves close collaboration with global regulatory teams in Denmark, as well as Novo Nordisk affiliates across the EU to ensure timely submissions. Excellent communication and English proficiency is a must, especially with the global perspective of the role. Stakeholder satisfaction is one of the departmental and individual goals, so service mindedness towards our stakeholders within Novo Nordisk is a key priority.  Our organisation is dynamic, with change management being an essential part of our everyday life. In addition, there is a constant focus on optimising our working processes, and you will be involved in cross functional improvement activities.

Candidate Profile
You should hold a Post Graduate or comparable degree in Science (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life Sciences, etc.) or equivalent professional experience and have at least two years of experience in Pharmaceutical Industry in Regulatory Affairs. Experience of compilation of dossier in eCTD, NeeS & Standard format and document Management system is preferred. Intermediate knowledge in MS-Office is preferred.  Because of the Global nature of work, we need you to have basic personal skills such as good communication skills, stakeholder management, detail oriented, readiness to change, service minded and customer oriented. We expect you to demonstrate a high-quality mindset and accountable towards your task. You should have the ability to work well as an individual and in teams.

Additional Information
Qualification : M.Pharm, M.Sc 
Location : Karnataka - Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 15th April, 2019

Require Regulatory Affairs Analyst at Novo Nordisk

Post : Regulatory Affairs Analyst

Job Description
As Regulatory Affair (RA) Associate Analyst, you will be responsible for compiling and supporting the submission of manufacturing sites globally. Your key responsibilities are facilitation of submission planning meetings with RA colleagues in different countries, compilation of national table of contents, table of contents (TOCs) based on the countries’ local requirements, coordination of registration sample and follow up with RA affiliates on final submission to health authority.

You will be delivering high quality registration dossiers, which require a good understanding of regulatory guidelines, regulatory Chemistry, Manufacturing and Control (CMC) documentation, different registration file formats and the Regulatory dossier compilation process.

The job involves close collaboration with global regulatory teams in Denmark and Bangalore, as well as Novo Nordisk affiliates across the globe to ensure timely submissions. Excellent communication and English proficiency is a must, especially with the global perspective of the role.  Stakeholder satisfaction is one of the departmental and individual goals, so service mindedness towards our stakeholders within Novo Nordisk is a key priority.  .

Candidate Profile
• You have a post graduate education in Science (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences) and experience in working with Regulatory Affairs for 3-5 years in handling eCTD/NeeS/National format dossier & Table of content compilation for different markets (US/EU & Rest of the World).
•  As a person, you thrive in a busy environment and you bring a can-do attitude. You’re a strong team player, but you also enjoy working independently.
•  You are a skilled communicator, who can collaborate with a lot of stakeholders and comfortable using your excellent written and spoken English proficiency daily. Furthermore, you have flair for IT systems and experience with MS Office.
• We expect you to be a good planner, well organised, service minded, positive, engaged and actively contribute to a good team spirit.

Additional Information
Qualification : M.Pharm, M.Sc 
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 1st April, 2019

Apply for Head of Regulatory Affairs Pharmacovigilance and Quality Assurance at Novo Nordisk

Post : Head of Regulatory Affairs Pharmacovigilance and Quality Assurance

Job Description
As a Head of Regulatory Affairs, Pharmacovigilance and Quality Assurance, you will represent India in global platform like AAMEO, IO and HQ and you will manage Regulatory Intelligence (legislation and guidelines within the pharmaceutical/healthcare industry) and local regulatory plans by ensuring regulatory approvals, license to operate aligned with local business demands.

The Position requires accountability like; Ensure maintenance of RA IT systems used in Novo Nordisk, Influence and Monitor local regulatory environment and ensure compliance, provide regulatory support and insight to external and internal stakeholders, Develop Affiliate level regulatory strategy and Implementation Plans (IPs) and Develop local RA teams.

Additionally, you also manage the local Quality Assurances and related team by ensuring timely completion of affiliate QA activities: documentation systems, Non- conformities and change control repacking, quality plans and QMR, products releases, audits, validation and destructions of safety reporting of observational studies, training and QBIQ administration, QC activities, local records, management business ethical training and documentation, etc.

Candidate Profile
• Post Graduate in Pharmaceutical, Medical Science or related field or relevant business orientation, Advanced degree preferred (PhD, MBA, MDs, MS)
• Advanced knowledge of pertinent local regulations required
• Experience with regulatory intelligence activities and pharmaceutical registration databases is preferred
• Knowledge of diabetes and diabetes management beneficial, Knowledge of other therapeutic areas and/or biotech products relevant to Novo Nordisk beneficial
• Fluent in spoken and written English
• Overall minimum of 10 years’ experience with a minimum of 5 years relevant experience required
• Previous supervisory/management experience required depending on team size

Additional Information
Qualification : M.Pharm, M.Sc, PhD, MBA, MDs, MS
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance
End Date : 10th February, 2019

Apply for Head of Regulatory Affairs Pharmacovigilance and Quality Assurance at Novo Nordisk @Apply Now

Post : Head of Regulatory Affairs Pharmacovigilance and Quality Assurance

Job Description
As a Head of Regulatory Affairs, Pharmacovigilance and Quality Assurance, you will represent India in global platform like AAMEO, IO and HQ and you will manage Regulatory Intelligence (legislation and guidelines within the pharmaceutical/healthcare industry) and local regulatory plans by ensuring regulatory approvals, license to operate aligned with local business demands.

The Position requires accountability like; Ensure maintenance of RA IT systems used in Novo Nordisk, Influence and Monitor local regulatory environment and ensure compliance, provide regulatory support and insight to external and internal stakeholders, Develop Affiliate level regulatory strategy and Implementation Plans (IPs) and Develop local RA teams.

Additionally, you also manage the local Quality Assurances and related team by ensuring timely completion of affiliate QA activities: documentation systems, Non- conformities and change control repacking, quality plans and QMR, products releases, audits, validation and destructions of safety reporting of observational studies, training and QBIQ administration, QC activities, local records, management business ethical training and documentation, etc.

Candidate Profile
• Post Graduate in Pharmaceutical, Medical Science or related field or relevant business orientation, Advanced degree preferred (PhD, MBA, MDs, MS)
• Advanced knowledge of pertinent local regulations required
• Experience with regulatory intelligence activities and pharmaceutical registration databases is preferred
• Knowledge of diabetes and diabetes management beneficial, Knowledge of other therapeutic areas and/or biotech products relevant to Novo Nordisk beneficial
• Fluent in spoken and written English
• Overall minimum of 10 years’ experience with a minimum of 5 years relevant experience required
• Previous supervisory/management experience required depending on team size

Additional Information
Qualification : M.Pharm, M.Sc, PhD, MBA, MDs, MS
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance
End Date : 10th February, 2019

Require Analyst in RIMS Data Management at Novo Nordisk @ Click Here for more details

Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).

Post : Analyst RIMS Data Management

About the department 
Global Regulatory Affairs in Bangalore consists of eight departments that work across our global processes and support both colleagues in Head Quarter (HQ) Denmark (DK) as well as colleagues in our affiliates all over the world. As the area is growing, the total area will by midyear 2019 consist of approximately 120 dedicated employees. Regulatory Operations, Global Service Centre (GSC) is an integral part of Regulatory Operations DK. The objective of this team is to ensure efficient and competitive Regulatory Operations to support Regulatory Affairs (RA) HQ and RA Affiliates. The team provides the services in Submission Management, Regulatory Information Management and Operational Graphic Design.

Job Description

• You will have to register data management, handle data entry tasks and should do the Quality Check and Verification.
• You will need to have a proactive approach regarding system and business process improvement and participates in testing and validations if any upgrade of system.    
• You need to participate and contribute in different process improvement projects as assigned and do the monitoring & training of new joiners and regular tasks.
• You will also have to ensure 100% quality for all work related to Regulatory Information Management System (RIMS) and be responsible for complying to procedures and systems

Candidate Profile
• Graduate / post graduate or Comparable degree in Science/ Pharmacy/ computer related field
• 6-8 years of experience
• Knowledge in Data Entry & Data Management
• Knowledge in Regulatory Affairs
• Knowledge in Register Database preferred
• Knowledge in MS-Office
• Active involvement in business processes
• Good Communication Skills
• Good subject knowledge in academics
• Detail oriented
• Take initiative, systematic and organised, thorough and analytical
• Is service minded and customer oriented
• Focuses on targets and delivers results
• Good at give guide, train & coordinate colleagues

Additional Information
Experience : 5+ years
Qualification : M.Sc., M.Pharm, B.Pharm, B.Sc
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare
Functional Area : RIMS Data Management
End Date : 25th January, 2019

Require Managers for Global Regulatory Affairs in Novo Nordisk @ Apply Now Click Here

Post : Managers for Global Regulatory Affairs

Job Description
Manager of RA Established Products
The department is currently being established and will be handling regulatory clinical activities within the established product portfolios.
The position holder will have a dotted line to CVP of RA Diabetes and Obesity and CVP of Biopharm in Denmark and in this way ensure functional alignment across the products and projects handled by the different departments.

Manager of RA Established Products, CMC & Devices 1
The department is currently responsible for all regulatory CMC and device aspects of the HRT (hormone replacement therapy) portfolio, glucagon portfolio and growth hormone portfolio in addition to a several device products. The position holder will have a dotted line to VP of RA CMC & Devices in Denmark and in this way ensure functional alignment across the products and projects handled by the different departments.

Manager of RA Established Products, CMC & Devices 2
The department is currently being established and responsibilities within the established product portfolios will transition from the Denmark unit to this team
The position will have a dotted line to VP of RA CMC & Devices in Denmark and in this way ensure functional alignment across the products and projects handled by the different departments.

As the Bangalore unit is expanding, these positions will play a key role in building strong teams and in strengthening the collaboration across the Global Regulatory Affairs organisation. While building the teams it will be critical to ensure people development and maintain high engagement in the teams.

All positions present an opportunity to demonstrate strong leadership in accordance with the company charter, which we at Novo Nordisk call the Novo Nordisk WAY. We expect that each position holder will lead with a strong focus on continuous improvement, while ensuring a high-quality mind-set and adherence to Novo Nordisk quality management system. As a leader, you will be expected to ensure optimal and flexible use of resources within the department, while continuing to develop, coach and support employees to achieve higher levels of professional competency for current and future roles.

Candidate Profile
You hold a Master of Science or other relevant Professional Degree (e.g. MD, PhD) combined with 5+ years’ experience from the pharmaceutical industry, preferably within global regulatory affairs organisation with project-based tasks.
You have strong people management skills, efficient negotiator and have good stakeholder management skills and lead by example and set direction. Furthermore, you motivate employees and keep engagement high in your department. You are flexible, quick to adapt and able to handle many responsibilities, while delivering results - Proactive and solution oriented. You hold good communication and presentation skills and is fluent in spoken and written English.

Additional Information
Experience : 5+ years
Qualification : MD, Ph.D
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare
Functional Area :  Regulatory Affairs
End Date : 15th December, 2018

Senior Associate required at Novo Nordisk

Post : RA Senior Associate

Job Description
As RA Senior Associate, you will be responsible for compiling and supporting the submission of manufacturing sites globally. The key responsibilities are: facilitation of submission planning meetings with RA colleagues in different countries, compilation of National Table of Contents TOCs based on the countries’ local requirements, request additional documentations from RA colleagues in HQ, as per the local requirements, coordination of registration samples when samples are required, quality Check of the registration dossiers, follow up with RA Affiliates on final submission to Health Authority   You will be delivering high quality registration dossiers, which require a good understanding of Regulatory guidelines, Regulatory CMC documentation, different registration file formats and the Regulatory dossier compilation process.

Career for Freshers B.Pharm as Associate at Novo Nordisk

Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 30,000 employees in 76 countries and markets its products in 179 countries. Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO).

Post : Associate I – Customer Complaints in Global Service Center

Job Description
Key Responsibilities:
• To perform final evaluation of Customer Complaint Cases without samples and to  enter the reported information in the Novo Nordisk complaint database (CCGloW)
• To enter off-line cases in CCGloW.
• To maintain a network of complaint contacts within: affiliates, CCC and investigators.
• To handle inquiries from affiliates and other departments in Novo Nordisk A/S