Instagram
youtube
Facebook

Senior Specialist Regulatory Project Management Office

8-14 years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: MSc./M. Pharm/PhD 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 Title: Regulatory Project Manager Officer

Location: Electronic City Phase 1, Bangalore


About the Company:

At our company, we are dedicated to breaking barriers, exploring new possibilities, and discovering more. Our colleagues across the globe are passionate about innovating with science and technology to enrich people’s lives in healthcare, life science, and electronics. We dream big and care deeply for our diverse mix of people, customers, patients, and the planet. We are constantly on the lookout for curious minds ready to imagine the unimaginable with us.


Your Role:

As a Regulatory Project Manager Officer, you will be an integral part of the Global Regulatory Affairs (GRA) Portfolio Management Team. Your primary responsibility will be to contribute to the strategic evolution of the function by managing timelines, risks, priorities, direct costs, and FTE demand for the GRSTs/IRSTs. You will work in a matrix organization, collaborating with various stakeholders to ensure resource efficiency and alignment with business priorities.


Key Responsibilities:

  • Project Management Office (PMO): Act as PMO for GRSTs, creating and evolving templates and tools that support the lifecycle of assets and ensure quick access to relevant, harmonized information.
  • Collaboration & Communication: Work closely with Regulatory Project Managers (RPMs) and Global Regulatory Leads (GRLs) to ensure that tools and templates are efficiently utilized across the GRSTs, facilitating a streamlined process.
  • Data & Reporting: Consolidate GRST relevant data on a quarterly basis, generating insights from reports to identify areas for improvement and contribute to a learning organization.
  • FTE Demand Planning: Be part of the FTE demand forecasting SME group and collaborate with various teams to generate insights and forecasts related to resource needs.
  • Healthcheck & KPIs: Collaborate with leaders in Therapeutic Areas (TA) such as Oncology (Onc) and Finer, to review and evolve metrics, KPIs, and the GRA Healthcheck, providing transparency and actionable recommendations.
  • Surveys & Insights: Conduct the annual GRST survey to assess team perception and provide feedback to improve overall team performance.
  • Collaboration with RQS Operations: Work closely with RQS operations and the Strategic Sourcing and Planning team to define reporting requirements and generate GRA insights.
  • System Stewardship: Act as the iMAP steward for GRA functions, managing system updates and ensuring data integrity across various regulatory teams.

Who You Are:

  • Experience: 8-14 years of experience in a pharmaceutical environment, competent authority, or academia/R&D, with at least 6-8 years in regulatory affairs or regulatory project management.
  • Education: Degree in Life Science, Medical, PharmD, or related discipline (minimum MSc or equivalent degree); higher degree (e.g., PhD) preferred. Advanced training in portfolio & project management is a plus.
  • Skills:
    • In-depth knowledge of regulatory, R&D processes, and technology solutions.
    • Strong business administration knowledge is a plus.
    • Proven experience in portfolio and project management.
    • Excellent analytical skills and the ability to generate actionable insights from complex data.
    • Ability to collaborate across functions and work in a matrix organization.
    • Strong communication skills, both written and verbal.
    • Ability to manage competing priorities and deliver high-quality results.

Financial Dimensions:

  • Support the RPMs to update the iMAP system for quarterly direct cost planning, consolidating demand and comparing actual spending against the GRA budget.

What We Offer:

We are committed to creating an inclusive culture where diversity is celebrated, and everyone can bring their best self to work. We believe that diversity drives excellence and innovation, helping us lead in science and technology. We are dedicated to offering opportunities for personal and professional growth, allowing you to develop at your own pace. Join us in building a culture of inclusion and belonging, and make an impact that empowers everyone to work their magic!


Apply Now:

Ready to explore, innovate, and grow with us? Apply today to join our diverse team and help shape the future of regulatory affairs!

Latest Jobs

Senior Medical Writer (Line Management Experience Required)

Prime Vigilance
Remote

Senior Medical Information Manager

Prime Vigilance
Remote

Senior Medical Writer (Line Management Experience Required)

Prime Vigilance
Hyderabad

Senior Medical Writer (Line Management Experience Required)

Prime Vigilance
Aachen Abbott Park Aberdeen Abilene Adelanto Ahmedabad Airoli Alameda Albany Albion Albuquerque Almaty Ambala Ambernath Ambler Amravati Amsterdam Anakapali Anantapur Anchorage Andover Ankleshwar Annamalainagar Appleton Arcata Argentina Arizona Arkansas Arlington Athens Atherton Atlanta Auckland Augusta Aurangabad Austin Australia Austria B.G Nagara Baddi Ballina Ballydine Baltimore Banasthali Bangalore Bangkok Bangor Barcelona Baroda Barrow Basel Basking Ridge Batavia Bathinda Baton Rouge Bavaria Bayreuth Be'Er Sheva Beijing Bel Air Bela Belgaum Belgium Belgrade Bellevue Bend Bengaluru Berkeley Berlin Bethel Bethlehem Bharuch Bhimavaram Bhiwadi Bhopal Bhubaneswar Biberach an der Riß Biddle Bielefeld Big Piney Bilaspur Billerica Birmingham Bishop Blacksburg Bloomfield Bloomingdale Bloomington Blue Ash Blue Bell Boca Raton Bochum Boerne Bogota Boise Bommasandra Bonn Boston Bothell Boulder Bountiful Branchburg Township Brazil Breda Brenham Brentwood Brewer Bridgeport Bridgewater Brinny Brisbane Bristol Brooklyn Brooksville Brunswick Brussels Bucharest Budapest Buenos Aires Buffalo Buffalo Grove Bulgaria Bulverde Burlingame Burlington Burney Cairo California Cambridge Canada Carlow Carlsbad Carolina Beach Carrollton Castlebar Cebu City Cedar Hill Champaign Chandigarh Chandler Chapel Hills Charleston Charlotte Charlottesville Chengdu Chennai Chessington Cheverly Chicago China Chittoor Cincinnati Ciudad de México Clark Clayton Clearwater Cleveland Coimbatore Cokeville Collegeville Cologne Colorado Columbia Columbus, Concord Cooper City Copenhagen Coquille Coral Gables Coral Springs Cork Corpus Christi Corsicana Corvallis Cranbury Crescent City Croatia Czech Republic Dalian Dallas Darmstadt Davis Dayton Daytona Beach Deerfield Dehradun Delhi Denmark Denton Denver Detroit Devens Dewas Dhule Dibrugarh Diburghar Dickinson Digha Dombivali Donegal Dortmund Downers Grove Downey Dubai Dublin Duisburg Duluth Dún Laoghaire Dunboyne Dunellen Durham Dusseldorf East Brunswick Eden Prairie Edgewood Edison El Monte El Paso El Segundo Elkridge Emeryville Enfield England Eot Municipality Erie Erlangen Erode Estonia Eugene Eureka Evendale Fairfield fairmont Falls Church Far Hills Faridabad Farmington Finland Flemington Florence Fort Smith Fort Worth Fortuna Foster City France Frank Scottile Blvd Frankfurt Franklin Freiburg Fremont French Friday Harbor Fridley Ft MItchell Fulton Gainesville Gaithersburg Gajraula Galway Gandhinagar Garden city Garland Gautam buddha Nagar Georgia Germany GErmany Ghaziabad Glendale Glenview Goa Goldendale Gorakhpur Gottingen Grants Pass Greater Noida Greece Green Way Grenzach Groton Gujarat Guntur Gurgaon Gurugram Guwahati Gwalior Hà Nội Haarlem Hackensack Hajipur Halifax Halle Halol Hamburg Hamilton Hammond Hangzhou Hannover Hanoi Hanumakonda Harlow Harrisburg Harrogate Hartford Harveysburg Haryana Hauppauge Hawai Hawthorne Hayward Hebron Heidelberg Heist op den Berg Hibbing Hicksville Hilo Hisar Ho Chi Minh City Holly Springs Hollywood Honolulu Hoopa Hopewell Houghton Lake Houston Huber Heights Hungary Hyderabad India Indianapolis Indore Ingelheim am Rhein Ireland Irvine Istanbul Italy Ithaca Jacksonville Jaipur Jakarta Jalgaon Japan Jeddah Jersey City Jhagadia Jhansi John Day Juneau Kannur Kansas City Karlsruhe Karnataka Keene Kenosha kentucky Kfar Saba Khandwa Khargone Khulais Kiel King Abdullah Economic City Kingman Kings Mills Knoxville Kochi Kolhapur Kolkata Konstanz Koropi Kuala Lumpur Kurkumbh Kurla Kurukshetra Kyiv La Jolla Lake Charles Lake Forest Lake Havasu City Lake Oswego Lakeview Lakeway Lancaster Largo Larne Las Vegas Latvia Lawrence Lebanon Leeds Leiden Leinster Leipzig Lendava Lenexa Leuven Lexington Lima Limerick Linden Linthicum Lisbon Livingston Lombard London Longview Los Angeles Louisville Lousiana Lucknow ludhiana Lumberton Lyndhurst Lyon Macedonia Macomb Macon Madhapur Madison Madrid Madurai Mahabubnagar Mahwah Maidenhead Mainz Maitland Malappuram Malaysia Manchester Mangalagiri Mangaluru Manila Manipal Maple Grove Marburg Marietta Marsa Martinez Mason Massachusetts Mathura Mcallen McFarland McKinleyville McPherson Mechanicsville Medak Medan Medford and Somerville Mehsana Melbourne Memphis Menlo Park Mesa Mexico Miami Michigan Middleburgh Middletown Midrand Milan Milford Millbrae Milpitas Minneapolis and St. Paul, Minnesota. Minnesota Minnetonka Mississauga Mitte Moga Mohali Monmouth Junction Monroe Montgomery Montreal Montville Morgan Hill Morningside Heights Morrisville Mount Arlington Mount Vernon Mountain View Mt. Pleasant Mukundapur Mumbai Munich Munster Mysore Nagercoil Nagpur Nainital Nairobi Najran Naperville Naples Narsapur Nashik Nashville Navi Mumbai Nebraska City Nedlands Nellore Netanya Netherlands Nevada New Brunswick New Delhi New Hampshire New Haven New Jersy New Orleans New York New Zealand Newark Newtown Niš Noida Norridge North Carolina North Miami Beach North Richland Hills North York Norway NOrway Norwood Novato Nutley Oakland Oeiras OH Oklahoma City Ooty Orange Oregoina Orlando Osaka Otemachi Oulu oxford Pacheco Palo Alto PAN-India Panaji Panchkula Paramus Paris Park City Park RIdge Parsippany Pasadena Passaic Paterson Patiala Patna Peapack-Gladstone Pearl River Pembroke Pines Peridot Peru Phagwara Philadelphia Philippines Phoenix Piedmont Pilani Pine Brook Pirbright Piscataway Township Pithampur Pittsburgh Plainsboro Plano Plantation Pleasant Prairie Pleasanton Plymouth Meeting Poland Pomona Pondicherry (Puducherry) Port St. Lucie Portage Portland Portugal Pottstown Poughkeepsie Prague Prayagraj Princeton Junction Pudupakkam Pullman Pune Pune city Pydibimavaram Quarry Bay Queensland Rabigh Radnor Rahway Raipur Rajpura Raleigh Ranchi Rangareddy Rangpo Raritan Redding Redwood City Reedsport Regensburg Remote Remote - Africa Remote - Europe Remote - Middle East Remote - South America (Latin Americal) Remote Australia Remote Korea Remote, USA Renfrew Rensselaer Rhinebeck Rho Richardson Richmond Hill Riga Ringaskiddy Rishikesh Riverside Riyadh Rockland Rockville Rocky Mount Rohtak Romania Rome Roorkee Roseburg Roseville Rostock Round Lake Rourkela Rueil-Malmaison Runcorn Saarbrucken Sacramento Saint Petersburg Saitama Salem Salisbury Salt Lake City San Antonio San Bernardino San Carlos San Diego San Francisco San Gabriel San Jose San Juan San Mateo San Rafael Sanford Santa Clara Santa Cruz Santa Fe Santa Monica Santiago Sao paulo Sarajevo Sarasota Satyamev Scottsdale Seattle Seguin Sellersville Seoul Serbia Shanghai Shi Sheffield Shelbyville Sherwood Shirpur Shivalik Shreveport Siliguri Simi Valley Singapore Sitka Slovakia Slovenia Sofia Solan Soledad Somerset Somerville South Africa South Plainfield South San Francisco South Windsor South Yarra Southampton Southfield Spain Sparta Spring House Springfield Springville Srivilliputtur St. Helena St. Louis St.Paul Stamford Stanford Stanton Stevenage Stirling Stockton Storrs Stuart Stuttgart Summit Sunnyvale Surabaya Surprise Sweden Switzerland Swords Sydney Sylmar Syracuse Tacoma Taipei Tallahassee Tallinn Tampa Tandalja Tarapur Tarasadi Tartu Tel Aviv Temecula Tempe Texas Thailand Thane Thiruvananthapuram Thousand Oaks Tiruchirappalli Tirupathi Titusville Tokyo Tonopah Tonopsh Towson Trenton Trichy Trivandrum Tubingen Tucson Tucumcari Tulsa Turkey Turku Tuscaloosa Tyler Udaipur Udupi Ujjain Ulm United Kingdom United States Upper Marlboro Utica Uxbridge Vadodara Valencia Vallejo Vancouver Vapi Varanasi Vedant Vellore Venica Verna Victoria Vienna Vietnam Vijayawada Vikhroli Virginia Visakhapatnam Waco Warren Grove Warsaw Washington Waterford Watertown Waukesha Wausau Wavre Waynesville Welwyn West Chester West Hartford West Lafayette West Orange West Palm Beach West Sacramento West Valley City Westfield Westminster Wharton Whippany White Plains Whitesboro Whittier Willits Wilmington Winston-Salem Winter Haven Witney Woodburn Woonsocket Wrangell Wuhan Wurzburg Wyomissing Xzagreb Yavne Yerawada Yogyakarta Yuma Zagreb Zaragoza Zaventem Zurich

Senior Clinical Research Associate

Navitas Life Sciences
Bangalore

Medical Physician Specialist I

Fortrea
Mumbai Remote

Associate Patient Data Specialist

Thermo Fisher Scientific
Remote

Associate -Clinical Trial Registry Writing

Lilly
Bangalore

Cmcpm Radiopharmaceuticals

Lilly
United States

Director - Clinical Research Physician

Lilly
United States