Manager Regulatory Affairs- International @ Bharat Serums Vaccines

Job Description

Role & responsibilities

1. Preparation and reviewing of CTD and ACTD dossier.

2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.

3. Co-ordination with plant for Regulatory compliances.

4. Timely achievement of monthly plan & timely query response.

5. Gap Analysis/Updation of Master data.

6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks.

7. Get feedback from all the countries for respective variation, and there timely submission.

8. renewals.

9. Master data Updating.

10. Follow ups with plant for documentation regularly and review meeting.

11. Tracking and reviewing of document requirements of upcoming new filing in ROW and Emerging markets

Must have experience

eCTD, CTD, Validation, ICH requirements, USFDA Filings, EMA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products.

Candidates with at least 7 to 9 years of relevant experience only must apply.

Candidate must have experience on Bio phrma products

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0 - 1 Yrs 1 - 2 Yrs 2 - 3 Yrs 3 - 4 Yrs 4 - 5 Yrs 5 - 6 Yrs 6 - 7 Yrs 7 - 8 Yrs 8 - 9 Yrs 9 - 10 Yrs 10 - 11 Yrs 11 - 12 Yrs 12 - 13 Yrs 13 - 14 Yrs 14 - 15 Yrs 15 - 16 Yrs 16 - 17 Yrs 17 - 18 Yrs 18 - 19 Yrs 19 - 20 Yrs 20 - 21 Yrs 21 - 22 Yrs 22 - 23 Yrs 23 - 24 Yrs 24 - 25 Yrs 25 - 26 Yrs 26 - 27 Yrs 27 - 28 Yrs 28 - 29 Yrs 29 - 30 Yrs 30+ Yrs

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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Accounting / Finance Advertising / MR / PR / Events Agriculture / Dairy Animation / Multimedia Architecture / Interior Design Astrology Automobile / Auto Ancillaries / Auto Components Aviation / Airline / Aerospace / Aeronautical Banking / Financial Services / Broking BPO / Call Center / ITeS Brewery / Distillery Broadcasting Cement / Building Material Chemical / Petro / Plastic / Rubber / Glass Consumer Electronics / Appliances / Durables Courier / Transportation / Freight Defence / Government Education / Teaching / Training Electricals / Switchgears Engineering / Construction / Cement / Metals Environment / Waste Management Export / Import / Trading Facility Management Fertilizers / Pesticides FMCG / Foods / Beverage Food Processing Furnishings / Ceramics / Sanitaryware / Electricals Gems / Jewellery Gifts / Toys / Stationary Government / Departmental Heat Ventilation / Air Conditioning Hotel / Restaurant Industrial Design Industrial Products / Heavy Machinery Insurance Internet / E-Commerce IT - Hardware / Networking IT - Software / Services KPO / Research / Analytics Leather / Leather Products Legal / Courts Logistics / Courier / Transportation Management Consulting / Strategy Manufacturing / Production Matrimony / Matchmaking Media / Entertainment Medical / Healthcare / Hospital Merchant Navy Metal / Iron / Steel MFI - Micro Finance Military / Police / Arms Ammunition Mining / Quarrying NBFC-Non Banking Financial Services NGO / Social Work Office Equipment / Automation Not Mentioned Paint / Art / Sculpture / Craft Paper / Wood Personal Care / Beauty Pharma / Biotech / Clinical Research Politics Power / Energy / Oil / Gas / Petroleum Printing / Publishing / Packaging Quality Certification Real Estate / Property Recruitment Services / RPO Religion / Spirituality Retail Security / Detective Services Semiconductors / Electronics Shipping / Marine Telecom / ISP Textile / Garments / Fashion Travel / Tourism / Hotels / Airlines / Railways Unskilled Labor / Domestic Help Veterinary Science / Pet Care Sports / Fitness / Beauty NBFC ( Non Banking Financial Services ) Manufacturing Travel / Tourism Medical / Healthcare FMCG / F/B Education / Training IT Services / Consulting Software Product BPO / Call Center BFSI Power / Energy Recruitment Services Pharma / Biotech Oil / Gas / Petroleum Banking Real Estate Financial Services Accounting / Auditing Square 1 Consulting Services Hiring For A reputed Chemical industry Consumer Durables / Electronics Media / Dotcom / Entertainment Engineering / Construction Investment Banking / Venture Capital / Private Equity Aviation / Airline Automation Export-Import / Trading Shipping Hospitality FinTech Automobile / Auto Ancillaries Others Printing / Packaging Broking Auto Components E-Learning Furnishings / Sanitaryware / Electricals Chemical / Plastic / Rubber / Glass 97 KPO / Analytics Sanskar HR Consultancy Services Hiring For Chemical Industry Emerging Technologies MFI ( Micro Finance ) Heat ventilation Air conditioning Heat ventilation Air conditioning Subhadra Jobs Consultancy Hiring For Bpo Industry Subhadra Jobs Consultancy Hiring For Bpo Industry Acme Services Private Limited Hiring For Beauty Skin Care Industry Semiconductors Semiconductors Mining Sanskar HR Consultancy Services Hiring For Manufacturing Industry Sports / Fitness AMOHA CONSULTING AND VENTURES PRIVATE LIMITED Hiring For Urgent | Hiring for Branch Sales Manager role in NBFC Industry for Navi Mumbai - 5.5 LPA (Micro LAP) Paint Railways Legal BPM / BPO, IT Services / Consulting, Leather Film / Music / Entertainment, Retail, BPO / Call Centre, Recruitment / Staffing, Software Product, Electronic Components / Semiconductors, Banking, Medical Services / Hospital (Diagnostics), Electrical Equipment, Facility Management Services, Analytics / KPO / Research, Medical Services / Hospital, Biotechnology, Accounting / Auditing, Internet, E-Learning / EdTech, Insurance, Education / Training, Financial Services (Asset Management), Chemicals (Paints), Financial Services (Broking), Pharmaceutical / Life Sciences, Financial Services, FMCG (Tobacco), Investment Banking / Venture Capital / Private Equity, Engineering / Construction, Iron / Steel, FinTech / Payments, Telecom / ISP, NBFC, Printing / Publishing, Travel / Tourism, Consumer Electronics / Appliances, Medical Devices / Equipment, NBFC (Micro Finance), Chemicals, Food Processing (Dairy), Internet (E-Commerce), Hardware / Networking, Real Estate, Emerging Technologies (Cloud), FMCG, Industrial Equipment / Machinery (Construction Equipment), Miscellaneous, Real Estate (Co-working), Gaming, Management Consulting, Hotels / Restaurants, Beauty / Personal Care, Advertising / Marketing, Agriculture / Forestry / Fishing, Automobile, Industrial Equipment / Machinery, Industrial Automation, Gems / Jewellery, Water Treatment / Waste Management, Automobile (Automobile Dealers), Design, Advertising / Marketing (Digital Marketing), Electronics Manufacturing (Electronic Manufacturing Services (EMS)), Power, Courier / Logistics, Building Material, Metals / Mining, Textile / Apparel (Fashion), Auto Components, Clinical Research / Contract Research, Emerging Technologies (AI/ML), Electronics Manufacturing, Events / Live Entertainment, Law Enforcement / Security Services, Agriculture / Forestry / Fishing (Agri-tech), Food Processing, Government / Public Administration, Petrochemical / Plastics / Rubber, Architecture / Interior Design, Import / Export, Packaging / Containers, Courier / Logistics (Logistics Tech), Legal, Industrial Equipment / Machinery (Machine Tools), Emerging Technologies, Beverage, Furniture / Furnishing, Furniture / Furnishing, NGO / Social Services / Industry Associations, Beverage (Brewery / Distillery), TV / Radio, Emerging Technologies (Nanotechnology), Sports / Leisure / Recreation, Oil / Gas, Defence / Aerospace, Textile / Apparel (Yarn / Fabric), Building Material (Glass), Power (Wind), Textile / Apparel, Aviation, Content Development / Language, Automobile (Electric Vehicle (EV)), Fitness / Wellness, Railways, Emerging Technologies (IoT), Military / Police / Arms / Ammunition Animation EmpowerHire Associates Hiring For Casting Forging industry Gaming Job Search Hiring For Manufacturing Industry Auto Components (Tyre), Emerging Technologies (Drones/Robotics), Power (Hydro), Food Processing (Meat / Poultry), Building Material (Ceramic), Animation / VFX, Pulp / Paper, Job Search Hiring For Reak Estate industry Fertilizers / Pesticides / Agro chemicals, Defence / Aerospace Jobs Territory Hiring For Business Development Manager-Jewellery industry Ports / Shipping, Government Department Sunergeo India Corporation Hiring For Manufacturing Industry AIM JOBS HR SERVICE Hiring For Garment Industry Zecruiters Jobconnect Private Limited Hiring For Taxtile Industry M-Corp Services Hiring For Leading Appliance Industry Client EmpowerHire Associates Hiring For Forging Industry Job Search Hiring For Financial Industry Transformatrix Global Private Limited Hiring For Banking Industry Aarvi Encon Limited Hiring For staffing industry Job Search Hiring For Pharma Industry IT Services u0026 Consulting Square 1 Consulting Services Hiring For a reputed manufacturing industry Power (Solar), Building Material (Cement), Emerging Technologies (AR/VR), Emerging Technologies (Cybersecurity), Textile / Apparel (Home Textile),

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Keyskills:   eCTD CTD ICH requirements WHO Prequalification Validation USFDA Filings