Specialist Regulatory Operations

7 days ago

Mumbai, Maharashtra, India ADVANZ PHARMA Full time

Location: Andheri, Mumbai

(Hybrid working opportunity)

About ADVANZ PHARMA

ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on.

Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.

Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.

ADVANZ PHARMA's product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.

We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.

About the Role

As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Specialist Regulatory Operations & Compliance support.

What You'll Do:

  • Co-ordination/management/lead XEVMPD/IDMP submissions, ensuring that electronic submissions meet the required quality standards with internal/external deadlines.
  • Provide subject matter expertise on ISO IDMP Standards, EU Implementation Guide, and SPOR, ePI, PLM, PMS, IRIS implementation.
  • IDMP operational strategy Leading and execution.
  • Assistance in the development and implementation of new Regulatory processes and the continuous improvement thereof.
  • Work closely across the company to implement, maintain, and ensure compliance of Electronic Document Management System, Publishing system and XEMPD/IDMP systems.
  • Networking and awareness activities that leads to a continuous stream of impending changes in electronic regulatory requirements.
  • Lead/manage XEVMPD/IDMP submissions creation maintenance and their QC and Compliance and All other XEVMPD/IDMP related activities.
  • Responsible for tracking and communicating the progress of submissions to the wider Regulatory function.
  • Responsible for IDMP related data migration, mapping, cleaning and data enrichment.
  • Support systems projects by participating in system validation and implementation of IDMP.
  • Participate in the migration of data between systems, as and when required.
  • Support with the maintenance and development of XEVMPD/IDMP procedure documents (SOP/WI) of regulatory systems processes.
  • Provide support and mentoring/training/troubleshooting to new systems users, by adopting a Super User/Process owner role for regulatory systems.
  • Lead all the data management activities of SPOR, Master data (IDMP related).
  • Responsible for providing the training, support, and the end user communication for data management topics and on IDMP intelligence.
  • Ensure regulatory/system compliance with Regulatory Processes by performing spot checks of data and documentation in the Regulatory Systems.
  • Assist in the development of a framework for resolution of compliance issues/risks
  • Support Product and Company M&A, with respect to data migration.
  • Ensure required portal and Gateway's access to regulatory team along with training, e.g. PLM, IRIS, ESG.

About You

We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients' lives.

For this role, you will also have the following:

Qualifications:

  • Formal training in Regulatory Affairs.
  • Graduate/Post-graduate in any discipline of science, preferably life science / Pharmacy.

Knowledge, Skills & Experience:

  • Significant experience of submissions of XEVMPD and submissions to EMA via gateway, its maintenance.
  • Hands on experience with validation/Implementing Regulatory systems for XEVMPD/ISO IDMP.
  • Knowledge of Electronic submissions requirements globally. (Including XEVMPD/IDMP).
  • Knowledge and hands on experience of electronic Document Management Systems (e.g. Veeva Vault RIM) and XEVMPD/IDMP tools.
  • Good understanding of ICH and regional regulatory guidelines – should be able to interpret guidelines and apply them in practical situations.
  • Good Project Management and Communication skills.
  • Pleasant personality with collaborative approach, interpersonal skills, high on team spirit
  • Demonstrate sense of drive and urgency through work.
  • Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented).
  • Assertive & Good Influencing skills.
  • A positive and 'can-do' approach, biased towards finding solutions and embracing change.
  • Inspired by our values of entrepreneurship, speed and integrity.
  • Learning agility and 'scalability', with a desire to continuously improve and develop as ADVANZ grows.
  • Work collaboratively across all business functions with an open, honest, and respectful cooperation.
  • Ability to have fun and thrive in a growing, unique, and inclusive work environment.

Why ADVANZ PHARMA?

The success of any company is driven by its people, and we are no different.

At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.

Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing and enhancing the specialty and hospital medicines they depend on.

As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you'll be empowered to own your work, explore new possibilities, and make things happen.

But there's more to you – and us – than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles – we have an active ADVANZ PHARMA Women's Network; almost 40% of our managers are women.

We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.

We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.

To join us on our exciting journey, Apply now *

*Please include a CV and Cover letter.

  • Specialist Regulatory Operations

    7 days ago

    Mumbai, Maharashtra, India ADVANZ PHARMA Full time

    Location: Andheri, Mumbai(Hybrid working opportunity)About ADVANZ PHARMAADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on.Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare...

  • Regulatory Affairs Specialist AMEA

    7 days ago

    Mumbai, Maharashtra, India Lifelancer Full time

    About the job We are looking for an experienced Regulatory Affairs Specialist to join our growing team, to assist CMR Senior Regulatory Affairs Specialist (AMEA) in all tasks relating to registrations for new or modified product. We are advertising this role to be based in Mumbai but we could be flexible on location in AMEA. About CMR Surgical CMR is an...

  • Regulatory Affairs Specialist AMEA

    7 days ago

    Mumbai, Maharashtra, India Lifelancer Full time

    About the job We are looking for an experienced Regulatory Affairs Specialist to join our growing team, to assist CMR Senior Regulatory Affairs Specialist (AMEA) in all tasks relating to registrations for new or modified product. We are advertising this role to be based in Mumbai but we could be flexible on location in AMEA. About CMR Surgical CMR is an...

  • regulatory operations and compliance

    7 days ago

    Mumbai, Maharashtra, India Randstad Full time

    Hi Greetings from Randstad we are hiring for Regulatory affairs specialist IDMP Responsibilities : Lead/manage XEVMPD/IDMP submissions creation maintenance and their QC andCompliance and All other XEVMPD/IDMP related activities.Responsible for tracking and communicating the progress of submissions to the widerRegulatory function.Responsible for IDMP related...

  • Analyst, Specialist, Regulatory Reporting, Technology and Operations

    7 days ago

    Mumbai, Maharashtra, India DBS Bank Full time

    Business Function Technology and Operations (T&O) enables and empowers the bank with an efficient, nimble and resilient infrastructure through a strategic focus on productivity, quality & control, technology, people capability and innovation. In Group T&O, we manage the majority of the Bank's operational processes and inspire to delight our business...

  • Specialist Regulatory Reporting

    7 days ago

    Mumbai, Maharashtra, India DBS Bank Full time

    Specialist Regulatory Reporting-(WD54921) Finance aims to deliver world-class standards in reporting, financial planning and finance processes. We provide insights and analyses that help the bank make sound business decisions – whether in the areas of product development or customer profitability. We also provide capital management, business planning,...

  • Specialist-Loan Operations

    7 days ago

    Navi Mumbai, Maharashtra, India IDFC FIRST Bank Full time

    Job title: Specialist-Loan Operations Function/Department: Operations Job Purpose: As part of the Treasury Operations team, candidate need to Ensure the processes and policies are compliant and streamlined within the Regulatory guidelines. He and she also need Ensure best-in class customer service in providing general banking support to clients....

  • India Regulatory Affairs Specialist, Mumbai

    1 week ago

    Mumbai, Maharashtra, India Bloomberg Full time

    India Regulatory Affairs Specialist, Mumbai Mumbai Posted Apr 12, Requisition No Bloomberg delivers critical information in a world where information matters. We give influential decision makers in business, finance and government an edge by connecting them to a dynamic network of news, people and ideas. To do that, we need a constant flow of...

  • Associate Regulatory Operations

    7 days ago

    Mumbai, Maharashtra, India Abbott Laboratories Full time

    Primary Job Function:With Manager Oversight:Supports Drug product lifecycle management activities for EPD Global Regulatory AffairsSpecific actions and responsibilities of individual contributor include but are not restricted to:Awareness of end-to-end processes of the Drug product lifecycle management Supports the Regulatory Operations be it related to...

  • Cards Operations- Regulatory Reporting:mumbai

    7 days ago

    Mumbai, Maharashtra, India Skillventory Full time

    **Cards Operations Regulatory ReportinG:Mumbai**: From 3 to 8 year(s) of experience- ₹ Not Disclosed by Recruiter MumbaiorRoles and ResponsibilitiesThe role holder is responsible for validating the system data and timely reporting to regulators and internal stakeholders.Ensuring all reporting are done accurately and timely mannerCo-ordinating with multiple...

  • Treasury Operations

    7 days ago

    Mumbai, Maharashtra, India InCred Financial Services Full time

    We are seeking a highly skilled and detail-oriented Treasury Operations Specialist to join our team.As a Treasury Operations Specialist, you will play a pivotal role in leading the company's treasury functions, ensuring efficient cash flow management, and optimizing our financial resources.Key Responsibilities:Cash Management Monitor daily cash balances and...

  • Treasury Operations

    7 days ago

    Mumbai, Maharashtra, India InCred Financial Services Full time

    We are seeking a highly skilled and detail-oriented Treasury Operations Specialist to join our team.As a Treasury Operations Specialist, you will play a pivotal role in leading the company's treasury functions, ensuring efficient cash flow management, and optimizing our financial resources.Key Responsibilities: Cash Management - Monitor daily cash balances...

  • Associate - Regulatory Operations

    7 days ago

    Mumbai, Maharashtra, India Sandoz Full time

    Your Key Responsibilities:Your responsibilities include, but not limited to:To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional secretarial service & assistance, and to contribute to the achievement of functional objectives. Learns to use basic principals, theories, and professional concepts. Applies company...

  • Specialist-Trade Finance Operations

    7 days ago

    Navi Mumbai, Maharashtra, India IDFC FIRST Bank Full time

    Job Title: Specialist – Trade Finance Operations Function / Department: Operations- Retail, Wholesale & Treasury Job Purpose: This role entails responsibility for planning, directing, and supervising the activities of staff in Wholesale Banking Operations, ensuring compliance with established procedures and guidelines, delivery of quality internal...

  • Regulatory Affairs Specialist

    7 days ago

    Mumbai, Maharashtra, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team. Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) - WFO Responsibilities: 1. Dossier...

  • Website Operations Specialist

    7 days ago

    Mumbai, Maharashtra, India Argus Media Full time

    Website Operations Specialist Location: Mumbai. About Argus: Argus is the leading independent provider of market intelligence to the global energy and commodity markets. We offer essential price assessments, news, analytics, consulting services, data science tools and industry conferences to illuminate complex and opaque commodity markets. Headquartered...

  • DP Marine Assurance Specialist

    7 days ago

    Mumbai, Maharashtra, India Faststream Recruitment Group Full time

    Job DescriptionAre you an ex Master Mariner or ex Chief Engineer with substantial working experience with DP systems in the offshore or marine sectors? A global company, known for delivering specialized marine engineering and consultancy services worldwide, is looking for a DP Marine Assurance Specialist to join their team in Mumbai.As DP Marine Assurance...

  • Regulatory Reporting

    7 days ago

    Mumbai, Maharashtra, India Pride Circle Full time

    Hiring LGBT Talent Only (LGBT stands for Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Pansexual, Bicurious)Job Title:Analyst Role (Regulatory Reporting) - _LGBT (OUT or CLOSETED)_Grade 1ALevel Level 1AReports to Team ManagerLocation MumbaiOverall Job PurposeTo provide a high-quality service for covering aspects of Transactional and Positional...

  • Executive- Regulatory Affairs, Regulatory

    7 days ago

    Mumbai, Maharashtra, India Apotex Research Private Limited Full time

    About Apotex Inc.Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the...

  • Head of Regulatory Desk

    7 days ago

    Mumbai, Maharashtra, India Riverforest Connections Private Limited Full time

    Position Purpose The Head of the Regulatory Desk in Compliance supports the Territory Chief Compliance Officer on ensuring local regulatory requirements are met, including Partnership with Business & Compliance Domain Heads : Partner and collaborating closely with the Compliance Domain Heads to provide SME support on regulatory topics related to the...