• Login / Signup
    • Instagram
    youtube
    Facebook

    Senior Regulatory Affairs Associate-Biologics

    Parexel
    4-8 years
    Not Disclosed
    Hyderabad
    10 Sept. 5, 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

    Senior Regulatory Affairs Associate

    Position Overview:

    We are seeking a Senior Regulatory Affairs Associate with 4-8 years of experience in the management of drug product life cycles, including both small molecules and biologics, across various markets. The ideal candidate will have a solid understanding of regulatory frameworks, regional trends, and the requirements for pre- and post-approval submissions.

    Key Responsibilities:

    • Regulatory Submissions:

      • Contribute to the preparation and delivery of regulatory maintenance submissions, ranging from simple to increasingly complex, from both global and regional perspectives.
      • Author and review documentation for Marketing Authorization Applications (MAAs) and Variations, ensuring compliance with EU procedures such as DCP, MRP, and National Procedures.
      • Prepare documentation for various Variation procedures, including Super Grouping, Grouping, and Work-sharing for Marketing Authorizations.
      • Manage post-approval CMC-related updates and safety variations, ensuring timely submission to Health Authorities.

    • Regulatory Framework and Compliance:

      • Demonstrate a thorough understanding of regulatory frameworks and trends for small and large molecules across all regions.
      • Handle CMC-related health authority queries and ensure compliance with global pharmaceutical legislation and guidance, particularly ICH requirements.
      • Review DMFs, batch records, specifications, and stability data to ensure regulatory compliance.

    • Cross-Functional Collaboration:

      • Liaise closely with cross-functional teams to align on product responsibilities and regulatory requirements.
      • Provide regulatory impact assessments for change proposals and identify necessary documentation for EU submissions.
      • Execute and maintain submission delivery plans and content plans, providing proactive status updates to stakeholders.

    • Regulatory Information Management:

      • Utilize Regulatory Information Management Systems, such as Veeva Vault, to manage and track submissions and regulatory activities.

    • Team Leadership:

      • Mentor and guide team members, leveraging strong communication skills to foster collaboration and ensure adherence to regulatory processes.

    Qualifications:

    • Experience: 4-8 years of relevant experience in regulatory affairs, handling both pre- and post-approval life cycle management for drug products (small molecules and biologics).
    • Knowledge:
      • In-depth understanding of EU and US regulatory procedures, including post-approval requirements.
      • Familiarity with regulatory frameworks in ROW markets is a plus.
      • Expertise in regulatory CMC aspects and global pharmaceutical legislation, particularly within ICH countries.
    • Skills:
      • Proficiency in Regulatory Information Management Systems like Veeva Vault.
      • Strong communication and leadership skills, with the ability to mentor and guide team members effectively.
    • Education: Relevant degree in life sciences or a related field.

    This role offers the opportunity to make a significant impact within a dynamic regulatory environment while advancing your career in a supportive and collaborative setting.

    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 |