• Login / Signup
    • Instagram
    youtube
    Facebook

    Associate Director/Director - Regulatory Affairs (Ema Expert)

    Medpace
    3-5 years
    Preferred by Comapny
    London
    10 Nov. 25, 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

    Job Opportunity: Associate Director/Director - Regulatory Affairs (EMA Expert)

    Location: London, United Kingdom
    Job Requisition ID: 10431
    Time Type: Full-Time, Office-Based

    About Medpace

    Medpace is a leading global contract research organization (CRO) that provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. We accelerate the development of safe and effective medical therapeutics using a scientific and disciplined approach. Headquartered in Cincinnati, Ohio, Medpace operates across 40+ countries.

    Role Overview

    We are currently seeking an Associate Director/Director of Regulatory Affairs to join our team in London. The successful candidate will lead and manage interactions with the European Medicines Agency (EMA), providing expert strategic input into global drug development plans. This role requires a deep understanding of the EMA regulatory processes and the ability to advise on global drug development strategies.

    Key Responsibilities

    • Regulatory Strategy Development: Provide expert regulatory advice and strategies to ensure compliance with industry standards, addressing regulatory challenges throughout the clinical development process.
    • Collaboration Across Teams: Partner with various development teams (Clinical Operations, Medical Writing, Clinical Safety, Data Management, etc.) to support regulatory needs, including gap analysis, regulatory meetings, and protocol reviews.
    • Expertise in EMA: Manage and guide regulatory interactions with the European Medicines Agency (EMA), advising on regulatory submissions and compliance strategies.
    • Regulatory Guidance: Advise project teams on the implementation of regulatory strategies and provide proactive solutions to regulatory issues.
    • Regulatory Updates: Maintain knowledge of evolving EMA regulations and global drug development requirements, ensuring teams are informed and compliant.

    Qualifications

    • Educational Requirements:
      • MD, PhD in Life Sciences, or an equivalent advanced degree.
    • Experience:
      • A minimum of 5 years of experience in regulatory drug development.
      • Expert knowledge of regulatory affairs, ideally in one or more therapeutic areas.
      • Professional experience working with the EMA, such as within a scientific committee, is preferred.
    • Skills:
      • Proven experience in regulatory affairs and global drug development.
      • Strong leadership skills with the ability to guide teams through complex regulatory processes.

    Travel

    • Less than 10% travel required.

    Why Medpace?

    Perks & Benefits

    • Flexible work environment and competitive salary/bonus program.
    • Generous PTO packages and health/wellness initiatives.
    • Career growth opportunities and company-sponsored employee events.
    • Equity grants and structured career paths for professional development.

    Recognition & Awards

    • Forbes: Recognized as one of America’s Most Successful Midsize Companies (2021, 2022, 2023, 2024).
    • CRO Leadership Awards: Awarded for expertise, quality, and capabilities by Life Science Leader Magazine.

    How to Apply

    To join Medpace and be part of a global leader in clinical development, visit Medpace’s website and apply referencing Job Requisition ID 10431.

    Join Medpace today and make a difference in global drug development!

    Latest Jobs

    Clinic Medical Director

    Doccafe
    Dickinson

    Clinic Medical Director Fp/Im

    Doccafe
    Frank Scottile Blvd

    Pacs Administrator

    Central Peninsula Hospital
    Remote, USA

    Biller / Collector

    Cibola General Hospital
    Remote, USA

    Authorization Coordinator Oncology

    Christus Health
    Santa Monica

    Healthcare Virtual Assistant - Ph

    Wing Assistance
    Remote

    Coding Specialist

    Ensemble Health Partners
    Remote

    Junior Accountant

    Nice Healthcare
    Remote, USA

    Entry Level Insurance Counselor I ( Dtla, California)

    Davita
    Los Angeles

    Duke Hematologic Malignancy Physician Scientist

    Duke Health
    Durham

    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 | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    India :

    Siliguri |

    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 |

    Arkansas :

    Fort Smith |

    California :

    Brisbane | California | Crescent City | Davis | El Monte | El Segundo | Emeryville | Foster City | Fremont | Glendale | 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 | South San Francisco | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Bridgeport | Enfield | Groton | Storrs |

    D.C :

    Washington |

    Florida :

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

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

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

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Garden city | Lawrence |

    Kenlucky :

    Shelbyville |

    Kington :

    Frank Scottile Blvd |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Gaithersburg | Rockville |

    Massachusetts :

    Andover | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |

    Michigan :

    Detroit | Houghton Lake |

    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 :

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

    North Carolina :

    Concord | Lumberton | North Carolina |

    North Caroline :

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

    North Dakota :

    Dickinson |

    Ohio :

    Cincinnati | Cleveland | Columbus, |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

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

    Portugal :

    Lisbon | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Nashville |

    Texas :

    Austin | Corsicana | Dallas | Houston | Richardson | Waco |

    United states :

    Georgia | United States |

    United States :

    Hawai |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Bothell | 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

    BULGARIA :

    Bulgaria |

    Denmark :

    Copenhagen |

    Europe :

    Latvia | Leuven | Poland | Spain |

    Finland :

    Finland |

    Hungary :

    Budapest |

    Istanbul :

    Istanbul | Turkey |

    Norway :

    Norway | NOrway |

    Romania :

    Romania |

    Serbia :

    Belgrade | Serbia |

    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 & Belgium & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Finland & France & Indonesia & Ireland & Israel & Japan & Korea & Netherland & Philippines & Portugal & Remote & Saudi Arabia & Singapore & South America & Spain & Taiwan & Tennessee & Thailand & Turkey & United Arab Emirates

    Buenos Aires :

    Buenos Aires |

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Antwerp :

    Heist op den Berg |

    Brussels :

    Brussels |

    Canada :

    Canada |

    Ontario :

    North York | Richmond Hill |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Leeds | London | Salt Lake City | Maidenhead | Harlow | Stirling |

    Estonia :

    Estonia |

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Lyon | Paris |

    Jakarta :

    Jakarta |

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Republic of Ireland :

    Dublin | Waterford | Limerick |

    Israel :

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

    Tokyo :

    Otemachi |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    Philippines :

    Manila |

    Remote :

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

    Makkah :

    Rabigh | Najran | Jeddah | Khulais | Riyadh |

    Singapore :

    Singapore |

    Brazil :

    Sao paulo |

    South America :

    Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Dubai :

    Dubai |