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Last updated: 1 day 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: 24 days ago
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PGT Geography Teacher for CBSE School in Srikar Rajasthan

PGT Geography Teacher for CBSE School in Srikar Rajasthan

EducoHireSri Madhopur, Rajasthan, India
PGT Geography Teacher for CBSE School in Srikar Rajasthan.Benefits Food and accommodation will be given.Skills Fluent communication skills. Qualification Bachelor / Master related to PGT Geography....Show moreLast updated: 30+ days ago
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Business Development Representative SDR

Business Development Representative SDR

Talent Giants Consultancy Services LLPBengaluru, Karnataka, India
₹1,000,000.00–₹1,400,000.00 yearly
Business Development Representative / SDR.As SaaS pricing evolves from vanilla subscriptionbased models to more granular usagebased models billing and pricing infrastructure needs to be completely r...Show moreLast updated: 30+ days ago
DAG - Art Advisor (Delhi)

DAG - Art Advisor (Delhi)

The Art X CompanyNew Delhi, DL, in
Quick Apply
DAG is seeking a knowledgeable and personable Art Advisor to join their team.The Art Advisor will play a pivotal role in guiding clients through the art buying process, providing expert advice on a...Show moreLast updated: 26 days ago
Travel Agent-Schedule Change (Mumbai)

Travel Agent-Schedule Change (Mumbai)

Etraveli GroupMumbai, MH, IN
Full-time
Quick Apply
Etraveli Group is the globally leading company for tech solutions and fulfillment capabilities for online sales of flights. We are here to solve complexity, by connecting millions of flights and tra...Show moreLast updated: 30+ days ago
Contracts Specialist

Contracts Specialist

Partner One CapitalIN
Remote
Full-time
Quick Apply
In business for over 25 years, Partner One Capital is one of the fastest-growing enterprise software groups in the world. Over 1000 of the world's largest corporations and governments rely on our so...Show moreLast updated: 30+ days ago
Sales Officer

Sales Officer

Exponent EnergyElectronic City, KA, IN
Full-time
Quick Apply
This team runs on a hustle mindset with an objective to increase Exponent Energy’s market share in the city of Bengaluru and beyond and help more people adapt to 15-minute rapid charging technology...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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Chemist- Quality- Wind Mill Blades

Chemist- Quality- Wind Mill Blades

Reliance Industries LimitedVadodara, Gujarat, India
₹700,000.00–₹1,400,000.00 yearly
Full-time
IMS Documentation as per required standards of ISO, EHS, ENV.To Analyse NDT inspection report to go next level.Plan to preparing QAP, Work Instruction, Procedure, Material specifications, Test Proc...Show moreLast updated: 23 days ago
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Findroids - TypeScript Specialist

Findroids - TypeScript Specialist

findroids.Chennai
Responsibilities : - Develop, test and maintain custom add-ins for Microsoft Excel in Office 365 cloud.Utilize the Office JavaScript API to interact with Excel objects and exte...Show moreLast updated: 30+ days ago
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Export Documnetation Coordinator

Export Documnetation Coordinator

Randstad IndiaMumbai, Maharashtra, India
Coordinate and prepare export document packages including delivery notes ATR.BLs sales contracts certificates of conformity and analysis certificate of origin and. Oversee the general work process f...Show moreLast updated: 30+ days ago
Tax Staff - Form 1041 Preparation

Tax Staff - Form 1041 Preparation

Kaufman RossinBengaluru, KA, IN
Full-time
Quick Apply
Seeking a new challenge where your professional and personal aspirations are not only possible but supported? Kaufman Rossin might be just the place for you!. As one of the top accounting firms in t...Show moreLast updated: 30+ days ago
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BFSI Recruiter - Work From Home

BFSI Recruiter - Work From Home

Abacus ConsultantsAnywhere in India
Remote
Quick Apply
Define Resourcing Strategy and deliver key priorities for the business e.Quality of Hiring, Employer Branding, Sourcing Strategy. To hire quality job candidates, which can save the company time and ...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
Talent Acquisition Associate

Talent Acquisition Associate

2070HealthMumbai, MH, IN
Quick Apply
India's premier Venture Studio, pioneering an innovation platform dedicated to building groundbreaking healthcare companies from the ground up. Our mission is to identify and seize disruptive opport...Show moreLast updated: 30+ days ago
Field Sales (Outside Sales) Representative

Field Sales (Outside Sales) Representative

EnerjazzNoida, UP, IN
Quick Apply
We are looking for a competitive Field Sales Representative to develop sales strategies and attract new clients.The successful salesperson will source new sales opportunities and close sales to ach...Show moreLast updated: 30+ days ago
Receptionist cum Telecaller

Receptionist cum Telecaller

Candari EnterpriseSurat, GJ, in
Quick Apply
Manage front desk operations and patient inquiries.Schedule and confirm appointments.Maintain patient records and documentation. Provide excellent customer service with a professional attitude.Stron...Show moreLast updated: 25 days ago
Platform Operation Specialist

Platform Operation Specialist

ZeroFoxBengaluru, KA, IN
Full-time
Quick Apply
In this position, you’ll join our Platform Operations team who supports ZeroFOX's cyber security solution that helps organizations manage information security risks across social media.Your work wi...Show moreLast updated: 30+ days ago
Presentation Specialist

Presentation Specialist

N Human Resources & Management SystemsBangalore North, KA, in
₹2,500,000.00 yearly
Quick Apply
We are seeking a highly skilled.The ideal candidate will have extensive experience in creating and delivering high-impact PowerPoint presentations, including visually engaging slides and impactful ...Show moreLast updated: 23 days ago
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ZUORA Billing Consultant

ZUORA Billing Consultant

1HResource SolutionsGurugram
Work you'll do As a Zuora Consultant, you'll work within an engagement team and be responsible to : - Lead the end-to-end implementation and conf...Show moreLast updated: 1 day ago
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Regulatory Consultant

Regulatory Consultant

LifelancerGurugram, Haryana, India
24 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

    Vacancy : 1