• Login / Signup
    • Instagram
    youtube
    Facebook

    Deputy Manager-Labelling Regulatory Affairs

    Piramal Pharma
    4+ years
    Not Disclosed
    Mumbai
    10 July 26, 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, 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

    Job Title: Regulatory Affairs Specialist – Labeling

    Department: Regulatory Affairs
    Business Unit: Piramal Critical Care
    Location: Kurla, Mumbai
    Travel: Low

    Job Overview:
    The Regulatory Affairs Specialist is responsible for managing all artworks and labeling components for Piramal Critical Care products globally. This role ensures adherence to labeling processes and compliance with innovator labeling, internal and external partners, and GMP standards. The position requires collaboration with cross-functional teams to ensure labeling documents and change requests are accurate, meet regulatory standards, and align with global regulations.

    Key Stakeholders:

    • Internal: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Leadership Team.
    • External: Country Distributors, Health Authorities (HA), Contract Manufacturing Organizations (CMOs), and external partners.

    Reporting Structure:
    Reports to the Manager – Labeling

    Experience:
    4 years of relevant regulatory experience, with global exposure including US, EU, and major Rest of World markets preferred.

    Key Competencies:

    • Strong interpersonal and organizational skills.
    • In-depth knowledge of Health Authority labeling regulations and requirements.
    • Self-directed, motivated, and accountable with a flexible approach.
    • Excellent work ethic and positive attitude in a fast-paced environment.
    • Project management skills are a plus.

    Key Responsibilities:

    • Oversee global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality and regulatory compliance, including evaluations, maintenance, reviews, and approvals with cross-functional teams.
    • Prepare labeling documents such as SmPC, PIL, and other texts for EU region submissions.
    • Coordinate with stakeholders for timely labeling submissions, approvals, and query resolution.
    • Proofread all types of label copy/annotations at all stages of development to ensure accuracy.
    • Create Structured Product Labeling (SPL) for US Human and Veterinary product submissions, drug listings, annual establishment registration, and GDUFA self-identification.
    • Monitor and process innovator-labeling updates for existing generic products, ensuring compliance with innovator updates through side-by-side comparisons with RLDs.
    • Coordinate the development and updates of Core Data Sheets (CCDS) and local labeling updates for Piramal Critical Care products.
    • Contribute to the development and review of labeling aspects included in promotional materials.
    • Develop and maintain a central repository for all labeling components.

    Qualifications:

    • Bachelor’s or Master’s degree in Pharmaceutical Sciences or a related field.

    Required Skills:

    • High accuracy and attention to detail.

    About Us:
    Piramal Critical Care (PCC), a subsidiary of Piramal Enterprises Limited, is a leading global player in hospital generics and the third-largest producer of inhaled anesthetics. With a commitment to delivering critical care solutions and maintaining sustainable and profitable growth, PCC operates in over 100 countries. The company’s product portfolio includes inhalation anesthetics like Sevoflurane, Isoflurane, and Halothane, as well as Intrathecal Baclofen therapy for spasticity management.

    PCC boasts state-of-the-art manufacturing facilities in the US and India and is dedicated to expanding its global footprint through new product innovations in critical care. The organization values corporate social responsibility, collaborating with partner organizations to support those in need and care for the environment.

    Equal Employment Opportunity:
    Piramal Group is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, ethnicity, religion, color, national origin, gender, sexual orientation, gender identity, age, disability, or other legally protected characteristics. We make employment decisions based on merit and qualifications and strive to provide equal opportunities in all personnel matters.

    Latest Jobs

    Manager, Cmc

    Pfizer
    Beijing

    Regulatory Affairs Department Assistant(Contractor)

    Pfizer
    Turkey

    Senior Scientist, Protein Chemistry

    Pfizer
    Remote, USA

    Medical Science Liaison

    Pfizer
    Philippines

    ​​Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences​

    Pfizer
    Remote, USA

    Associate Central Monitor, Data Surveillance, Clinical Data Sciences

    Pfizer
    Remote, USA

    Clinical Research Associate

    Clinexel Life Sciences Pvt. Ltd.
    Mumbai

    Project Manager

    Clinexel Life Sciences Pvt. Ltd.
    Mumbai

    Biostatistician

    Clinexel Life Sciences Pvt. Ltd.
    Mumbai

    Database (Programming) Analyst (Associate), Clinical Data Management

    Pfizer
    Remote, USA

    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 |

    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

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Wrangell |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Peridot | 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 :

    Storrs |

    D.C :

    Washington |

    Florida :

    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 |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Rockville |

    Massachusetts :

    Boston | Cambridge | Medford and Somerville | Rockland |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | 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 | Syracuse |

    North Caroline :

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

    Ohio :

    Columbus, |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

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

    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 |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    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 |

    Serbia :

    Belgrade |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Tokiyo :

    Osaka | Tokyo |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    London | Salt Lake City |

    Republic of Ireland :

    Dublin | Limerick |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Remote :

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

    Makkah :

    Riyadh | Najran | Jeddah | Khulais | Rabigh |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |