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Jobs in Goa india

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Regulatory Affairs Specialist

UpMan PlacementsGoa, India

Regulatory Submissions and compliance.Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test...Show more

Materials Assistant

Grand HyattGoa, India

You will be responsible to provide an excellent and consistent level of administrative support to your customers.The Materials Clerk is responsible to assist the Materials Manager in the smooth ope...Show more

Team Member Production

Papa JohnsGoa, India

Is What Makes Us Better! Diversity is our strength and competitive advantage.Bring your flavor to the Papa John's team today!.Come Join the Better Ingredients, Better Pizza Team!.We are looking for...Show more

Associate Production

AbbottGoa, India

Plan, organize and achieve the outputs for each shift and reporting to the management any problems and issues that need interventions from the Company.Ensure safety and security of personnel and re...Show more

Sales Associate - Goa - Goa Hub

lenskart.comGoa, India

Skip Level – Areas Operations Manager.With a mission to give India a vision, Lenskart.India's fastest growing eyewear company.Lenskart's products include prescription eyewear, branded contact lense...Show more

Room Attendant

karma group globalGoa, India

Karma Group is an award-winning international Private Members Club offering exceptional experiences in the world's most sought-after destinations.With a global portfolio of 42 luxury resorts, fine ...Show more

Team Member Production

Papa Johns, IndiaGoa, India

Is What Makes Us Better! Diversity is our strength and competitive advantage.Bring your flavor to the Papa John's team today!.Come Join the Better Ingredients, Better Pizza Team!.We are looking for...Show more

Marketing Associate

pw (physicswallah)Goa, India

Job Role: Marketing Associate – Offline Field Marketing.You will be responsible for driving B2B sales, generating leads, connecting with locals, and organizing brand campaigns.Your efforts will dir...Show more

AVP Sales

Vianaar HomesGoa, India

We are seeking an ambitious, dynamic, and results-oriented.AVP (Assistant Vice President) of Sales.The AVP Sales will be responsible for driving direct sales growth, leading a team of real estate p...Show more

Bartender (Dubai/Abu Dhabi Based)

confidential jobsGoa, India

We are looking for a skilled and enthusiastic.The ideal candidate will be passionate about providing excellent guest service, preparing and serving drinks to the highest standards, and creating a w...Show more

Property Supervisor - Multi Skill Technician

stayvistaGoa, India

India's largest villa hospitality brand.Our handpicked luxury villas are present in every famous holiday destination across the country.We curate unique experiences paired with top-notch hospitalit...Show more

Production Supervisor_ Surface Treatment plant

SiemensGoa

Education & experience: Diploma in Chemical engineering with 5 years experience or B.Chemical Engineering with 3 years experience.Experience in chemical treatment plant.Explosive Chemicals Storage ...Show more

Operation Assistant

Endure Technology SolutionsGoa, India

Operation Assistant (0 - 3 years).Handle company compliances such as Trade License and Shops & Establishment.Maintain proper documentation and records of all compliance activities.Coordinate with 1...Show more

Medical Representative

HaystackAnalyticsGoa, India

Associate - Business Development (Full Time).HaystackAnalytics is a rapidly growing IIT Bombay based Health Company which is disrupting clinical genomics to improve patient outcomes across several ...Show more

Maintenance Execution L1-2

Sanofi IndiaGoa, India

Reliability & Methods Specialist.Goa Site, Verna Industrial Estate, Salcete, Goa, India.Sanofi is a global biopharmaceutical company focused on human health, dedicated to supporting people through ...Show more

Loss Prevention Host

st. regis hotels & resortsGoa, India

Regis Goa Resort, 438 1 34 Mobor, Goa, India, India, 403731 VIEW ON MAP.Patrol all areas of the property; assist guests with room access.Monitor Closed Circuit Televisions, perimeter alarm system, ...Show more

Audit Retrieval Specialist - Remote

SharecareGoa, India
Remote

Sharecare is a digital healthcare company that delivers software and tech-enabled services to stakeholders across the healthcare ecosystem to help improve care quality, drive better outcomes, and l...Show more

Maintenance Coordinator

PentairGoa, India

Basic knowledge in Electrical and engineering safety.Troubleshooting knowledge on PLC's and VFD's of Allen Bradley, Delta, Siemens and instrument controller programming, installation and commission...Show more

Commercial Sales Representative

Snider Fleet SolutionsGoa, India

We are committed to excellence and recognize the dedication it takes to do a great job.If you take pride in your work and are passionate about sales and building long-term relationships, we want yo...Show more

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Regulatory Affairs Specialist

Regulatory Affairs Specialist

UpMan PlacementsGoa, India
18 days ago
Job description

Core Job Responsibilities:

Regulatory Submissions and compliance

  • Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
  • Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
  • Ensure timely submissions and approvals for all regulatory filings.
  • Evaluate technical and scientific data for regulatory submissions.
  • Liaise with health authorities for inspections, clarifications, and approvals.
  • Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.

Product & Business Support

  • Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
  • Provide regulatory support for internalization and externalization of products.
  • To provide site CMC documents to international business team to support export registration.

Documentation & Quality Oversight

  • Maintain and update regulatory databases, trackers, licenses, and approvals.
  • Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
  • Evaluate and approve site change controls and Change Request evaluation forms.
  • Provide working standards/specifications and CoAs to regulatory authorities and internal teams.

Tender Certificates

  • To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
  • Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.

Governance, SOPs & Training

  • Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
  • Deliver training on GMP, regulatory updates, and SOPs at the site level.
  • Approve SCNs from Corporate QA and review reports from regulatory authorities.

Additional Responsibilities

  • Complete assigned trainings on time
  • Perform other duties as assigned by the Regulatory Affairs leadership.
  • Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.

Position Accountability/Scope:

  • · Responsible for all regulatory activities for the manufacturing site mainly LL sites.
  • · Ensures site compliance with applicable national regulations and Abbott standards.
  • Supports business continuity through proactive regulatory planning and execution.
  • Minimum Education:

    B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.

    Minimum Experience/Training Required:

    • GOA FDA Mandatory
    • Manager: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
    • Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.


    Skills Required
    Regulatory Submissions, Quality Assurance