Regulatory Affairs

4 days ago

Hyderabad Telangana, India Talental Consultings Full time

Designation Senior Executive Assistant Manager Manager Sr Manager based on experience Industry Pharmaceutical - API Manufacturing Experience 3-15 Years flexible Qualification M Sc Chemistry or equivalent Key Responsibilities Prepare compile review and submit regulatory dossiers for APIs for Regulated markets Handle DMF Type II ASMF CEP and CTD eCTD submissions Manage regulatory submissions for markets such as USFDA EDQM EMA WHO CDSCO TGA PMDA ANVISA etc Prepare and submit variations amendments renewals and responses to regulatory queries Coordinate with R D QA QC Production and Analytical teams for dossier data collection Review process changes impurity profiles stability data and assess regulatory impact Support regulatory inspections and audits related to API filings Maintain regulatory compliance with current global guidelines ICH FDA EMA Track changes in global regulatory requirements and update internal stakeholders Maintain and archive regulatory documentation as per SOPs Required Skills Competencies Strong knowledge of API regulatory submissions and lifecycle management Hands-on experience with DMF CEP filings is mandatory Understanding of ICH guidelines Q1-Q14 and regulatory frameworks Ability to interpret technical data related to synthesis impurities and specifications Excellent coordination and documentation skills Exposure to eCTD tools is an added advantage Preferred Experience Experience working with regulated market API filings Prior exposure to multiple authorities and complex submissions API manufacturing company background preferred

  • Hiring for Regulatory Affairs

    2 days ago

    Hyderabad, Telangana, India Saraca Solutions Full time

    Hyderabad **Job ID**: SS202500077 **Function**: Quality **Role**: Regulatory Affairs **Desired Skills**: Regulatory, EU-MDR, Document, International Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports to be used in...

  • Associate Global Regulatory Affairs Compliance

    7 days ago

    Madhapur, Hyderabad, Telangana, India Makrocare Full time

    **Job Purpose**: Thisrole provides operational support for the implementation within GlobalRegulatory Affairs of the Internal Control Framework (ICF) elements such asrisk assessment, written standards and control, training, management monitoring(MM) and responding to problem (CAPA/CC/deviation management) also supportingregulatory community in internal...

  • Regulatory Affairs

    1 week ago

    Hyderabad, Telangana, India SMART TALENT SOLUTION Full time

    Regulatory Affairs (RA) professional in the pharmaceutical industry is to act as the bridge between the company and government health authorities, Their main goal is to ensure that all pharmaceutical products are safe, effective, high-quality, and meet all the legal and scientific requirements before they can be sold to the public.Job Type: Full-timePay:...

  • Associate Regulatory Affairs

    7 days ago

    Madhapur, Hyderabad, Telangana, India Makrocare Full time

    Company Description **MakroCare |** **_A MakroGroup Company_**- MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,...

  • Regulatory Affairs Executive

    1 week ago

    Hyderabad, India MakroCare Full time

    MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region...

  • Regulatory Affairs Associate – Regulatory Information Management

    3 weeks ago

    Hyderabad, Telangana Bangalore, Karnataka, India UST Full time

    Job Title Regulatory Affairs Associate - Regulatory Information Management RIM - UST Band B1 Role detailed classification RIM Regulatory Information Management Job Summary We are seeking highly skilled and experienced Life Sciences LS Regulatory Affairs RA Associate - RIM to join our LS Practice team The successful candidate will be responsible for LS...

  • Expert Regulatory Affairs Specialist

    6 days ago

    hyderabad, India beBeeRegulatory Full time

    Regulatory Affairs Professional OpportunityAs a key player in our organization, you will be responsible for overseeing regulatory submissions across various countries.Main Responsibilities:Compile and submit comprehensive dossiers to global health authorities.Conduct thorough gap analysis and identify necessary document and data gaps.Prepare dossiers in...

  • Executive - Enterprise Risk and Regulatory Affairs

    1 week ago

    Hyderabad, Telangana, India IQ-EQ Full time

    **Company Description** IQ-EQ is a leading Investor Services group which combines global expertise with an unwavering focus on client service delivery. We support fund managers, global companies, family offices and private clients operating worldwide. IQEQ is a preeminent service provider to the alternative asset industry. IQEQ works with managers in...

  • Regulatory Affairs Executive

    2 days ago

    Hyderabad, India SFC Full time

    Handling regulatory affairs in the pharma field. **Salary**: ₹200,000.00 - ₹600,000.00 per year **Benefits**: - Paid sick time - Paid time off Schedule: - Day shift Supplemental pay types: - Yearly bonus Ability to commute/relocate: - Hyderabad, Telangana: Reliably commute or planning to relocate before starting work...

  • Regulatory Affairs Specialist

    2 weeks ago

    Hyderabad, Telangana, India Medtronic Full time ₹ 1,00,00,000 - ₹ 2,00,00,000 per year

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeRegulatory Affairs Specialist In this exciting role as a Regulatory Affair Specialist, you will...