Position: Associate – Regulatory Affairs
Location: Chennai, India
Employment Type: Contract
Experience: 0 – 6 months
Job Overview
The Associate – Regulatory Affairs will support regulatory compliance and documentation activities for formulations and raw materials, ensuring adherence to local, regional, and global regulatory standards. The role involves reviewing product composition data, maintaining documentation accuracy, and collaborating with cross-functional teams to ensure timely project completion and product compliance for Johnson & Johnson (J&J) portfolios.
Key Responsibilities
1. Regulatory Review & Approval
Collaborate with local operating companies to review and approve formulations, raw materials, and constituent data.
Ensure the completeness, accuracy, and compliance of product information, including:
Trade name
Manufacturer
INCI name
CAS/EINECS numbers
Percentage composition
Regional and global regulatory requirements
2. Compliance Evaluation
Evaluate the regulatory impact of new, existing, or modified materials and formulations.
Assess compliance for innovation platforms, new product development, and marketed products against local and global regulations as well as internal J&J standards.
Identify and communicate potential compliance or documentation issues to relevant J&J stakeholders.
3. Documentation & Reporting
Prepare, compile, and maintain regulatory documentation in collaboration with cross-functional partners.
Ensure adherence to J&J best practice documents and standard work instructions for material and formulation reviews.
Provide weekly status updates to Client’s PR&S Designated Regulatory Interface (DRI).
Conduct portfolio surveys and maintain organized records for audit readiness.
4. Project Coordination & Implementation
Support development of project implementation plans with Client’s PR&S DRI team.
Manage workload effectively to ensure on-time delivery of all assigned projects.
Participate in training and mentoring activities for offshore teams to enhance regulatory review efficiency.
Deliverables
Regulatory compliance assessments for new, existing, and changed materials.
Compliance evaluations for formulations across innovation, development, and marketed product portfolios.
Accurate and timely regulatory documentation and reporting.
Weekly progress reports and training sessions for offshore regulatory teams.
Completed portfolio survey reports and data summaries.
Qualifications & Skills
Education:
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
Skills & Abilities:
Strong understanding of regulatory compliance principles and cosmetic/chemical material regulations.
Familiarity with INCI, CAS/EINECS, and global raw material data standards.
Excellent attention to detail, data verification, and documentation accuracy.
Strong communication and collaboration skills for cross-functional teamwork.
Ability to analyze compliance impacts and manage multiple priorities effectively.
Proficient in Microsoft Office and regulatory database tools.
Key Competencies
Regulatory Documentation
Material & Formulation Review
Compliance Evaluation
Cross-functional Collaboration
Project Management
Quality & Accuracy in Data
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Pondicherry (Puducherry) |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
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Berlin |Germany :
Germany | GErmany |Hesse :
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Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
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Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
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Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
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Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Mississauga | Uxbridge | Australia | North York | Richmond Hill | Renfrew |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
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Surabaya |Jakarta :
Jakarta |Israel :
Tel Aviv | Yavne | Netanya | Be'Er Sheva | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Japan :
Saitama | Japan |Tokyo :
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Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |New Zealand :
New Zealand |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
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Manila |Mazovia :
Warsaw |Remote :
Leinster | Faridabad | Remote | French | Hammond | Green Way | Thailand | Tulsa | Bountiful | Switzerland | McFarland | Slovakia | Bishop | Xzagreb | Blue Bell | Riga | Manipal | Belgium | Victoria | Springville | Ireland | Melbourne | Nairobi | Remote - Europe | Remote - Africa | Lousiana | Medan | Zaragoza | Remote - South America (Latin Americal) | Lenexa | Remote - Middle East | Hungary | Castlebar | Remote, USA | Texas | Minnesota |Bucharest :
Bucharest |Makkah :
Rabigh | Riyadh | Jeddah | Najran | Khulais | King Abdullah Economic City |Nišava District :
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Singapore |South Africa :
South Africa | Midrand |Brazil :
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Peru | Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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