Executive – Regulatory Affairs & Pharmacovigilance
Company: Ferring Pharmaceuticals
Location: Mumbai, India
Job Type: Full-Time
Experience: 1+ Years (Regulatory Affairs & Pharmacovigilance)
Qualification: Bachelor’s in Pharmacy / Life Sciences / Microbiology / Chemistry or related field
Salary Range: Not Specified
Job Overview
Ferring Pharmaceuticals is seeking an Executive – Regulatory Affairs & Pharmacovigilance to support safety reporting, regulatory submissions, and compliance activities across India and South Asia markets.
The role involves handling pharmacovigilance reporting, regulatory documentation, and lifecycle management of pharmaceutical products while coordinating with global teams and regulatory authorities.
Key Responsibilities
Pharmacovigilance Activities
Report safety information from India and South Asia cluster to Global Safety teams.
Follow up with reporters for additional safety information.
Monitor and manage safety mailbox.
Perform monthly reconciliation and compliance checks from a PV perspective.
Submit Periodic Safety Update Reports (PSURs) to regulatory authorities.
Regulatory Affairs
Prepare and compile dossiers for submission to Indian regulatory authorities.
Handle submissions for new products, clinical trials, variations, and renewals.
Prepare responses to regulatory queries.
Coordinate with global teams for regulatory requirements and submissions.
Regional Regulatory Support
Support regulatory submissions and follow-ups for South Asia countries.
Contribute to preparation for regulatory authority and expert committee meetings.
Labeling & Compliance
Prepare and update product labeling materials.
Review promotional materials to ensure compliance with product registrations.
Maintain compliance with regulatory standards and guidelines.
Database & Documentation Management
Update regulatory databases with accurate and timely information.
Maintain and update local SOPs.
Manage and renew Safety Agreements with partners, manufacturers, and distributors.
Pricing & Lifecycle Management
Coordinate pricing updates and ensure timely entry into National Pharmaceutical Pricing Authority database.
Support lifecycle management activities.
Inform commercial teams about key regulatory milestones.
Required Skills
Regulatory & PV Knowledge
Basic understanding of regulatory affairs and pharmacovigilance processes.
Knowledge of Indian regulatory requirements and submission processes.
Familiarity with safety reporting and PSUR submissions.
Communication & Coordination
Strong communication and follow-up skills.
Ability to coordinate with cross-functional and global teams.
Good documentation and reporting skills.
Organizational Skills
Ability to manage multiple regulatory and PV tasks.
Strong attention to detail and compliance.
Preferred Qualifications
Experience in pharma or biotech industry.
Exposure to South Asia regulatory environments.
Familiarity with regulatory databases and safety systems.
Key Competencies
Regulatory submissions and dossier preparation
Pharmacovigilance and safety reporting
Compliance and documentation
Cross-functional coordination
Lifecycle and labeling management
About the Company
Ferring Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies in reproductive medicine, maternal health, gastroenterology, and urology, with a strong presence across international markets.
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Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Digha | Kolkata | Mukundapur |Goa :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Hilo | Honolulu |Tennessee :
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Mexico |northeastern :
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Tuscaloosa |D.C :
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Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Uxbridge | Australia | Richmond Hill | Renfrew | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya | Yavne |Remote :
Switzerland | Faridabad | Thailand | Minnesota | Lousiana | Remote | Lenexa | Remote - Africa | Springville | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Middle East | Victoria | Manipal | Nairobi | Ireland | Remote - South America (Latin Americal) | French | Texas | Tulsa | Bishop | Green Way | Xzagreb | McFarland | Bountiful | Hungary | Leinster | Zaragoza | Blue Bell | Riga | Castlebar | Belgium | Slovakia | Hammond | Medan | Remote - Europe | Melbourne | Remote, USA |Republic of Colombia :
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Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
Rabigh | King Abdullah Economic City | Jeddah | Riyadh | Najran | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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