• Login / Signup
    • Instagram
    youtube
    Facebook

    Manager/ Sr. Manager - Regulatory Affairs

    Lambda Therapeutic Research
    2+ years
    Not Disclosed
    Ahmedabad
    10 Aug. 13, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Organizational Overview

    Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad, India. We operate with facilities in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA), and Fargo (USA), employing over 1,500 staff worldwide.

    With over 20 years of experience in providing full-spectrum clinical trial solutions, Lambda Therapeutic Research offers comprehensive services to the biopharmaceutical and generic industries. Our team of highly qualified and experienced industry leaders applies innovative technologies and therapeutic expertise, driven by a commitment to quality, to help clients develop products safely, effectively, and swiftly.

    At Lambda, our employees are the cornerstone of our quality promise. We are dedicated to hiring qualified and energetic individuals who strive for excellence to join our team.

    Job Details

    Job Role: Manager/Sr. Manager - Regulatory Affairs
    Reporting To: Head of Department/Project Head
    Department: Regulatory Affairs
    Location: Ahmedabad
    Overall Purpose: Coordinate and support the submission of dossiers to the DGCI and other regulatory bodies.

    Key Deliverables:

    • Lead and manage the regulatory affairs team.
    • Oversee regulatory functions, including submission of dossiers to DCGI, Zonal office, and other regulatory bodies for BE NOC, CT NOC, T-license, etc., via SUGAM and NSWS portals.
    • Follow up with CDSCO officials to expedite application processing and obtain approvals.
    • Lead discussions with DCGI/CDSCO officials on technical queries.
    • Report Serious Adverse Events (SAEs) on SUGAM and NSWS portals.
    • Provide technical guidance for preparing and submitting responses to DCGI queries.
    • Notify regulatory bodies about approved documents.
    • Provide feasibility inputs for upcoming projects from a regulatory perspective.
    • Conduct literature searches for product submissions and maintain knowledge of regulatory status.
    • Maintain a daily tracker for submitted applications.
    • Review and upload regulatory, DCGI, and Ethics Committee (EC) documents to the eTMF software.
    • Submit study information on the CTRI site for registration.
    • Prepare applications for CBN submissions for narcotic and psychotropic products.

    Allied Responsibilities:

    • Perform additional tasks as assigned by the Head of the Department or Project Head.

    Experience:

    • Minimum of 2 years of experience in regulatory affairs.

    Educational Qualification:

    • Bachelor’s or Master’s degree in Pharmacy.

    Competencies:

    • Accountability: Taking ownership of tasks and responsibilities.
    • Communication: Effective verbal and written communication skills.
    • Work Ethic: Demonstrates reliability and dedication.
    • Initiative: Proactively addressing challenges and seeking improvements.
    • Leadership: Ability to lead and guide team members.
    • Technical Knowledge: Expertise in regulatory affairs and submission processes.
    • Motivation/Initiative: Drive to achieve results and improve processes.
    • Interpersonal/Leadership Skills: Ability to build relationships and lead teams.
    • Presentation/Communication Skills: Skill in presenting and communicating information.
    • Organizational Culture Fit: Alignment with company values and culture.
    • Flexibility/Planning & Organizing: Adaptability and effective management of tasks.

    Accomplishments & Strengths:

    • Proven achievements in managing regulatory affairs and submission processes.
    • Effective communication and coordination with regulatory bodies.

    Latest Jobs

    Regulatory & Start Up Specialist I, Us Support, Cfsp

    Iqvia
    Mexico

    Fsp - Sr. Regulatory & Start Up Specialist

    Iqvia
    Buenos Aires

    Assoc Manager, Regulatory & Start Up (Fsp)

    Iqvia
    Buenos Aires

    Regulatory And Start Up Specialist - Romania

    Iqvia
    Romania

    Regulatory & Start Up Specialist, Cfsp

    Iqvia
    Mexico

    Manager, Regulatory And Start-Up

    Iqvia
    Durham

    Regulatory Affairs Global Labeling Lead

    Iqvia
    Bengaluru

    Sr. Specialist, Global Medical Affairs (Hst)

    Baxter
    Raleigh

    Medical Scientific Liaison (M/W/D)

    Baxter
    Germany

    Team Leader, Pv

    Baxter
    Ahmedabad

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

    Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |

    Maharashtra :

    Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |

    PAN-India :

    Panjab :

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Jaipur | Pilani | Udaipur |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Wrangell |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |

    California :

    Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Groton | Storrs |

    D.C :

    Washington |

    Florida :

    Clearwater | Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Gaithersburg | Rockville |

    Massachusetts :

    Boston | Cambridge | Devens | Medford and Somerville | Rockland |

    Michigan :

    Detroit |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New York :

    Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |

    North Carolina :

    Concord |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |

    Ohio :

    Cincinnati | Cleveland | Columbus, |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

    Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |

    Portugal :

    Lisbon |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Goldendale | Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Wyoming :

    Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Germany :

    Germany | GErmany |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Denmark :

    Copenhagen |

    Hungary :

    Budapest |

    Istanbul :

    Turkey |

    Romania :

    Romania |

    Serbia :

    Belgrade |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Pharma Jobs in Argentina & Australia & Canada & Colombia & Croatia & Egypt & England & Indonesia & Ireland & Israel & Japan & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    Buenos Aires :

    Buenos Aires |

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Ontario :

    North York | Richmond Hill |

    Quebec :

    Montreal |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Harlow | Salt Lake City | London |

    Jakarta :

    Jakarta |

    County Dublin :

    Swords |

    Republic of Ireland :

    Dublin | Waterford | Limerick |

    Israel :

    Netanya | Tel Aviv | Kfar Saba | Be'Er Sheva |

    Tokyo :

    Otemachi |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Noord Holland :

    Haarlem |

    Remote :

    Remote - Europe | Remote, USA | Remote | Switzerland |

    Makkah :

    Jeddah | Rabigh | Najran | Riyadh | Khulais |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |