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Last updated: 4 days ago
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Regulatory Consultant

Regulatory Consultant

LifelancerGurugram, Haryana, India
Regulatory Consultant (EU market experience).Regulatory Consultant (EU market experience).Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to acceler...Show moreLast updated: 30+ days ago
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Odoo ERP Consultant

Odoo ERP Consultant

Target IntegrationGurgaon
Role Description : We are seeking a highly skilled Senior Odoo ERP Consultant to join our team.This is a full-time on-site role at Target Integration, where you will be respons...Show moreLast updated: 22 days ago
Office coordinator

Office coordinator

NaukripayGurgaon Kty., HR, in
Quick Apply
An office coordinator manages office operations and administrative tasks, including scheduling, filing, and correspondence. They may also be responsible for ordering supplies, submitting work orders...Show moreLast updated: 10 days ago
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Signiminds - Splunk Consultant

Signiminds - Splunk Consultant

SIGNIMINDS TECHNOLOGIES PRIVATE LIMITEDGurugram
Title : Splunk Consultant (5+ Years) Location : Gurgaon Fulltime (Signiminds) Show moreLast updated: 20 days ago
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StrideOne - Deal Support Role

StrideOne - Deal Support Role

Stride OneGurgaon, India
Deal Support StrideOne is more than an NBFC; we are a financial institution for Indian startups and businesses, offering a full suite of financial services under the 'One' umbrella.As a ...Show moreLast updated: 29 days ago
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Portfolio Coordinator

Portfolio Coordinator

McCormick & CompanyGurugram, HARYANA, IN
The IT PFM Metrics, Reporting & Compliance Analyst is responsible for managing the OneIT PFM platform and monitoring the resource transactions tool. This will be accomplished by successfully imp...Show moreLast updated: 9 days ago
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Consultant - Dgtl Trnf

Consultant - Dgtl Trnf

WNS Global ServicesGurgaon, India
Position Overview : We are seeking a dynamic and strategic Director of Digital Transformation to lead our efforts in integrating advanced digital solutions (Contact center solutions AIML GenrativeAI...Show moreLast updated: 4 days ago
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Power Platform Specialist

Power Platform Specialist

ZyoinGurgaon
Job Description : Key Responsibilities : - Lead the design, development, and impl...Show moreLast updated: 30+ days ago
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Vikgol - Manual Tester

Vikgol - Manual Tester

VikgolGurgaon
Job Summary : We are looking for a detail-oriented and reliable QA Manual Tester to join our dynamic team.The successful candidate will be responsible for manually testing soft...Show moreLast updated: 30+ days ago
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Admission Counselor Female needed for a Pre School and DayCare in Gurgaon Haryana-122018

Admission Counselor Female needed for a Pre School and DayCare in Gurgaon Haryana-122018

EducoHireGurgaon, Haryana, India
Admission Counselor (Female) needed for a Pre School and DayCare in Gurgaon Haryana122018.Graduation / Post Graduation in Sales Marketing Psychology or a related field. Excellent communication social ...Show moreLast updated: 30+ days ago
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B2B Sales

B2B Sales

Akshya Patra ServicesGurgaon, Haryana, India
₹348,000.00–₹420,000.00 yearly
The B2B Sales role is crucial for driving revenue growth and developing strong relationships with our business clients.This position requires a proactive and resultsdriven individual who can identi...Show moreLast updated: 30+ days ago
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Sales Trainer

Sales Trainer

AgrimGurgaon, Haryana, India
Agrim is a B2B ecommerce marketplace for agriproducts categorized in seeds agrochemicals agrotools & animal feed.Identify the training need analysis of the team. Evaluate employee performance to...Show moreLast updated: 30+ days ago
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Frontend Development Consultant - HTML5 / CSS3

Frontend Development Consultant - HTML5 / CSS3

1HResource SolutionsGurgaon
We are seeking a highly skilled and experienced Frontend Development Consultant to join our team.As a consultant, you will play a critical role in collaborating with designers, back-end developers,...Show moreLast updated: 30+ days ago
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B2B Enterprise Sales Specialist - Telecom

B2B Enterprise Sales Specialist - Telecom

Global IT CombineDelhi NCR, India
Minimum Qualification : Graduate / MBA.Required Qualifications & Skills : - Min.Generation, SME and Enterprise Sales, including self-generated outbound leads within the Enter...Show moreLast updated: 7 days ago
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Great Value Capital - Fundraising Specialist - AIF Products

Great Value Capital - Fundraising Specialist - AIF Products

GreatvaluerealtyDelhi NCR, India
Job Description : Fundraising Specialist - AIF Products Location : Mumbai / Delhi Great Value Capital (GVC) is a Category-II Alternative Investment Fund (AI...Show moreLast updated: 9 days ago
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BharatRohan - Marketing & Branding Specialist

BharatRohan - Marketing & Branding Specialist

BharatRohanGurgaon, India
Experience : - 2-5 years (preferably in corporate communications) Role Overview : ...Show moreLast updated: 6 days ago
International Chat process opening for experience candidates in a leading MNC Gurgaon

International Chat process opening for experience candidates in a leading MNC Gurgaon

2comsGurgaon, HR, in
Quick Apply
International Customer Support Chat Position at a Leading MNC in Gurgaon.Our client is a global professional services company with leading expertise in digital, cloud, and security.They offer Strat...Show moreLast updated: 30+ days ago
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CDP Specialist - Adobe Experience Platform

CDP Specialist - Adobe Experience Platform

taggedGurugram
JD for CDP Specialist : As a CDP Specialist, you will be responsible for building, optimizing, and managing a robust customer data ecosystem to support personalized marketing s...Show moreLast updated: 30+ days ago
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EDM Consultant

EDM Consultant

myGworkGurgaon, India
This job is with S&P Global, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.About the Rol...Show moreLast updated: 23 days ago
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Talent Administrator Coordinator

Talent Administrator Coordinator

CieloGurugram, Haryana, India
Talent Administrator & Coordinator.Assist with recruitment and interview process.Completes and reviews screening assessment and document candidate responses effectively screening in or out of t...Show moreLast updated: 30+ days ago
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Regulatory Consultant

Regulatory Consultant

LifelancerGurugram, Haryana, India
30+ days ago
Job description

Job Title : Regulatory Consultant (EU market experience)

Job Location : Gurugram Haryana India

Job Location Type : Onsite

Job Contract Type : Fulltime

Job Seniority Level : MidSenior level

Description

Regulatory Consultant (EU market experience)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a FullService environment you’ll collaborate with passionate problem solvers innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives.

Discover what our 29000 employees across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts backgrounds cultures and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

For noncomplex and complex submissions independently fulfill the following responsibilities :

  • Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses product development plans and other regulatory submissions.
  • Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND for preapproval submission packages for product registration applications and for postapproval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
  • Manage and / or operationalize the delivery of daytoday regulatory activities for assigned project according to agreed timelines scope of contract budgets and strategies.
  • Participate as regulatory support on multidisciplinary project teams which may include clinical and other technical experts to develop products throughout their life cycle.
  • Act as a subject matter expert and help the team members with daytoday trouble shooting activities presenting solutions to project related problems.
  • Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
  • Support meetings with clients to discuss proposals the status of ongoing projects and as part of general business development activities.
  • Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
  • Prepare training materials and share best practices in the regulatory area both internally and externally.
  • Participate as regulatory support in internal or external project audits.
  • Participate as regulatory support on internal crossfunctional initiatives.
  • Contribute to the creation and / or maintenance of SOPs and other process related documentation as required.
  • Provide support in oversight to team members in the execution of their project responsibilities.
  • Capable of identifying when to ensure line support required to provide additional guidance and direction.
  • Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.
  • Qualifications

    What we’re looking for

  • Should have minimum 3yrs of CMC module 3 experience for EU market.
  • BS or PhD degree preferably in a sciencerelated field or equivalent experience in science / regulatory / medical writingrelated field. Moderate pharmaceutical / medical device related experience.
  • Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND PMA NDA MAA and CTD including electronic submissions.
  • Excellent interpersonal / communication skills including excellent written and verbal communication skills.
  • Excellent customer service skills with the ability to work both as a team member and independently.
  • Good quality management skills.
  • Advanced skills in Microsoft Office Applications.
  • Ability to interact with staff from multiple departments and offices to establish project standards.
  • Good initiative adaptability and proactivity.
  • Strong analytical skills good attention to detail.
  • Ability to work concurrently on projects each with specific instructions that may differ from project to project.
  • Fluent in speaking writing and reading English.
  • Get to know Syneos Health

    Over the past 5 years we have worked with 94% of all Novel FDA Approved Drugs 95% of EMA Authorized Products and over 200 Studies across 73000 Sites and 675000 Trial patients.

    No matter what your role is you’ll take the initiative and challenge the status quo with us in a highly competitive and everchanging environment. Learn more about Syneos Health.

    Additional Information

    Tasks duties and responsibilities as listed in this job description are not exhaustive. The Company at its sole discretion and with no prior notice may assign other tasks duties and job responsibilities. Equivalent experience skills and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company at its sole discretion will determine what constitutes as equivalent to the qualifications described above. Further nothing contained herein should be construed to create an employment contract. Occasionally required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates including the implementation of the EU Equality Directive in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act including the provision of reasonable accommodations when appropriate to assist employees or applicants to perform the essential functions of the job.

    Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.

    For more details and to find similar roles please check out the below Lifelancer link.

    jobs / view / a0bfd332bfd1131be402116

    Apply on Lifelancer Platform

    Key Skills

    Hair And Beauty,Facilities,IT Support,Bank,Asp.Net MVC

    Employment Type : Full Time

    Experience : years

    Vacancy : 1