Global Regulatory Professional

3 weeks ago

Gurgaon, India GE Healthcare Full time

**Job Description Summary**: As a Global Regulatory Affairs professional with expertise within Regulatory Affairs marketed products you will be supporting Marketing Authorisation activities from a full lifecycle management perspective, offering technical expertise and obtaining relevant approvals where required. You will be responsible for providing support to regulatory submissions in an efficient and timely manner through cross collaboration with multiple stakeholders and uphold “right first time” submission quality and timeliness.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

**Roles and Responsibilities**

In this role you will:

- Interpret regulations, guidelines and requirement and act as a Regulatory expert responsible for complete lifecycle management of submissions MAA - Marketing Authorization Application (various European procedures, ROW - Rest of the World, MAAs), Renewals (Europe and Non-Europe) and variations (RA - Regulatory Activities such as Safety updates, Labelling updates, administrative updates. & Quality variations) starting from strategic discussions with cross-functional teams (internal & third party), preparation of packages in line with regulations, coordinating with the CMC - Chemistry Manufacturing Control team to get CMC documentation and also with the publishing team to get the output ready as per market need, dispatch to markets, follow-up submissions until made and track until approval.
- Work closely with line manager and Global Regulatory product leads (GRPL), as directed, to ensure that submission strategies are executed as per HA requirements to achieve efficient positive outcomes.
- Be responsible for ensuring information relating to allocated submissions is uploaded into the Regulatory information management database as per the standard documented procedures.
- Ensure that relevant KPIs within the lifecycle of regulatory submissions, as defined in standard procedures, are met.
- Work with cross functional teams as needed, to plan and execute regulatory submissions.
- Participate in projects related to improving the processes, standards, and learning sharing.
- Escalate issues/risk to regulatory submissions at the right time with sufficient information.
- Support global regulatory or technical initiatives or act as a representative on behalf of regulatory team, as needed.
- Write or review regulatory standard operating procedures or cross functional procedures, as needed.

**Required Qualifications**
- Bachelor’s degree in life sciences or related discipline
- Extensive Regulatory Affairs experience is essential in pharmaceutical or radiopharmaceuticals domain, with knowledge of regulatory requirements in major regions (Europe, United States, and Rest of the World) both in CMC and RA submissions
- Adept at Regulatory strategy and/or submission execution
- Expert in planning and delivering work on time keeping first time quality in mind
- Hands-on experience with Regulatory information management systems (e.g., Veeva Vault) would be a plus.
- Willing to travel when required, but not more than 5-10%

**Desired Characteristics**
- Strong interpersonal skills and ability to engage effectively with colleagues at all levels
- Ability to resolve day-to-day issues, escalating issues that impact strategic initiatives
- Experience working with outsource partners an advantage

**Inclusion and Diversity**

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

LI-LM1

**Additional Information**:
**Relocation Assistance Provided**:No

  • Regulatory Affairs Professional

    3 weeks ago

    Gurgaon, India Siemens Mobility Full time

    Internal Title: Regulatory Affairs Professional External Title: Deputy General Manager Position Summary This position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL's diagnostic imaging & therapy medical devices to be...

  • Regulatory Affairs Professional

    3 weeks ago

    Gurgaon, India Siemens Healthineers Full time

    **Internal Title**:Regulatory Affairs Professional **External Title**:Deputy General Manager **Position Summary** This position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL's diagnostic imaging & therapy medical...

  • Regulatory Affairs Professional

    1 week ago

    Gurgaon, Haryana, India Siemens Healthineers Full time

    Internal Title:Regulatory Affairs ProfessionalExternal Title:Deputy General ManagerPosition SummaryThis position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL's IVD devices & medical devices to be sold in India.This...

  • Regulatory Affairs Professional

    1 week ago

    Gurgaon, Haryana, India Siemens Healthineers Full time

    Internal Title:Regulatory Affairs ProfessionalExternal Title:Deputy General ManagerPosition SummaryThis position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL's diagnostic imaging & therapy medical devices to be sold...

  • Regulatory Affairs Professional

    1 week ago

    Gurgaon, Haryana, India Siemens Healthcare Private Limited Full time

    Job Responsibilities: Responsible to interact with local marketing, global RA teams & make applications, clarify to queries, following up with CDSCO for licenses of IVD devices and medical devices regulated under Medical Device Rules 2017. Responsible to obtain new wholesale license of IVD devices & medical devices from state FDA, renew/amend existing...

  • Research Associate, Global Policy, Professional

    2 months ago

    Gurgaon, India FiscalNote Full time

    **About the Position** - We’re in search of a Junior Policy Analyst to act as a client advocate and an extension of our Global Professional Services team. You will be a part of the Professional Services team, working directly with the team to ensure our clients receive timely information about legislative and regulatory issues that impact our clients’...

  • Research Associate, Global Policy, Professional

    1 week ago

    Gurgaon, Haryana, India FiscalNote Full time

    About the Position We're in search of a Junior Policy Analyst to act as a client advocate and an extension of our Global Professional Services team. You will be a part of the Professional Services team, working directly with the team to ensure our clients receive timely information about legislative and regulatory issues that impact our clients' businesses....

  • Regulatory Operations Assistant

    2 days ago

    Gurgaon, Haryana, India Reckitt Full time

    We are ReckittHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a...

  • Regulatory Operations Assistant

    1 week ago

    Gurgaon, Haryana, India Reckitt Full time

    Regulatory Operations Assistant City: Gurugram We are ReckittHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest...

  • Regulatory Operations Assistant

    1 week ago

    Gurgaon, Haryana, India Reckitt Full time

    Home to the world's best loved and trusted hygiene, health, and nutrition brands.Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...

  • Regulatory Affairs Officer

    3 weeks ago

    Gurgaon, India Manpower Group Full time

    **Position : Associate Manager** The primary role of this position is to support regulatory compliance, maintenance and continual improvement of the company with applicable regulatory requirements, business objectives, and customer needs. - Ensure regulatory compliance with relevant global medical device regulations, including but not limited to FDA 21 CFR...

  • Global Mobility Executive

    2 months ago

    Gurgaon, India S&P Global Full time

    The Role - Global Mobility Executive Location - Gurugram, India **What’s in it for you**: This is a unique opportunity to join an ambitious People Experience team with a strong vision at a great time in the growth of S&P Global. At S&P Global the People Experience team sits at the heart of the People strategy and we are looking for a strong Global...

  • Regulatory Intelligence Lead

    1 week ago

    Gurgaon, Haryana, India SUN PHARMA Full time

    Summary: Under the leadership of the Senior Director (Head), Global Regulatory Intelligence and Policy (GRIP), partner with enterprise leadership to answer potentially sophisticated questions based on the ability to efficiently obtain, analyze, and summarize external information (notably global precedents and/or regulations) to facilitate efficient drug...

  • Svp Regulatory Reporting

    2 months ago

    Gurgaon, India HSBC Full time

    -Job description **Some careers have more impact than others.** If you’re looking for a career where you can make a real impression, join HSBC and discover how valued you’ll be. HSBC is one of the largest banking and financial services organisations in the world, with operations in 62 countries and territories. We aim to be where the growth is,...

  • Svp Regulatory Reporting

    2 days ago

    Gurgaon, India HSBC Full time

    -Job description **Some careers have more impact than others.** If you’re looking for a career where you can make a real impression, join HSBC and discover how valued you’ll be. HSBC is one of the largest banking and financial services organisations in the world, with operations in 62 countries and territories. We aim to be where the growth is,...

  • Global Mobility Executive

    1 week ago

    Gurgaon, Haryana, India S&P Global Full time

    The Role - Global Mobility ExecutiveLocation - Gurugram, IndiaWhat's in it for you:This is a unique opportunity to join an ambitious People Experience team with a strong vision at a great time in the growth of S&P Global. At S&P Global the People Experience team sits at the heart of the People strategy and we are looking for a strong Global Mobility...

  • Sales Support Professional

    3 weeks ago

    Gurgaon, India Siemens Healthineers Full time

    Siemens Healthineers is looking for a Sales Support Professional for Bid Management function. **Responsibilities**: - Search for relevant Govt tenders on various E-procurement platforms and GeM and sharing the same with respective regions and Stakeholder. - Coordination with various internal stakeholders (Product Managers, Commercial, Service, BU, Legal,...

  • Regulatory Operations Assocaite

    1 week ago

    Gurgaon, Haryana, India Reckitt Full time

    Regulatory Operations Assocaite City: Gurugram We are ReckittHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest...

  • Officer - Regulatory Affairs (Agrochemical)

    4 weeks ago

    Gurgaon, India Om Sai Global HR Services Full time

    _**Roles and Responsibilities**_ - To have a clear understanding of regulatory guidelines and data requirement for pesticide export. - Collect and coordinate information to prepare regulatory documentation for submission to regulatory agencies - Coordinating for Domestic and International Product registration. - Preparation of Product related Dossiers. -...

  • Regulatory Operations Assocaite

    1 week ago

    Gurgaon, Haryana, India Reckitt Full time

    Home to the world's best loved and trusted hygiene, health, and nutrition brands.Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...