Job Title:
Manager / Senior Manager - Regulatory Affairs
Location:
Gurgaon, Haryana, India
Company:
Lilly
Job Description:
The Manager / Senior Manager in Regulatory Affairs will manage the operational and technical aspects of regulatory affairs for the marketing affiliate. This includes executing regulatory plans for product registrations, ensuring compliance with local regulations, collaborating with cross-functional teams, and facilitating interactions with regulatory bodies.
Key Responsibilities:
Regulatory Plan Execution:
Implement regulatory plans in alignment with affiliate business and regulatory requirements.
Ensure submission and approval of regulatory applications within planned timelines.
Support product launches and anticipate regulatory constraints.
Regulatory Compliance:
Ensure that products comply with local regulations and quality system requirements.
Maintain regulatory archives and ensure timely submission of post-approval activities like renewals and variations.
Provide regulatory quality oversight for third parties and raise awareness of compliance issues.
Labelling:
Ensure that product information complies with local regulatory requirements.
Follow global labelling procedures to ensure accurate product information.
Process Improvement:
Actively participate in cross-functional teams and provide regulatory input.
Support affiliate training and education on regulatory matters.
Personal and Professional Development:
Stay updated with local and global regulatory procedures.
Attend external symposia or conferences to enhance technical expertise.
Required Qualifications:
Education:
Bachelor's degree or equivalent in a relevant scientific subject.
Experience:
At least one year of industry-related experience in regulatory affairs.
Experience dealing with regulatory agencies and healthcare systems.
Skills:
Teamworking and results-oriented skills.
Analytical, problem-solving, and negotiation skills.
Strong communication and project management skills.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji | Verna |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Kurla | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
Bhubaneswar | Rourkela |PAN-India :
Panjab :
Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore |Uttar Pradesh :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
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Hilo | Honolulu |Idaho :
Boise |Illinois :
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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 :
Hebron | Nebraska City |Nevada :
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Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
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Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Dún Laoghaire |Meath :
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China | Quarry Bay |Hubei :
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Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
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 :
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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 :
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Sarajevo |Sofia City :
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Canada |Ontario :
Renfrew | North York | Mississauga | Richmond Hill | Uxbridge |Quebec :
Montreal |Chile :
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Croatia |Zagreb :
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Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
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North Ostrobothnia :
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Turku |France :
Paris | Lyon |Attica :
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Surabaya |Jakarta :
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Be'Er Sheva | Tel Aviv | Netanya | Yavne | Kfar Saba |Italy :
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Remote Korea |Republic of Korea :
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Remote | Remote - South America (Latin Americal) | Remote - Africa | Remote, USA | Switzerland | Remote - Middle East | Remote - Europe |Bucharest :
Bucharest |Makkah :
King Abdullah Economic City | Riyadh | Jeddah | Najran | Rabigh | Khulais |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand | South Africa |Brazil :
Brazil | Sao paulo |South America :
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Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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Dubai |Hà Nội :
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Ho Chi Minh City |