Experience: Around 2 to 4 years of relevant experience in handling pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.
Regulatory Framework: Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
Submission Preparation: Contribute to the preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
EU/US Regulatory Procedures: Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage.
CMC Handling: Experience in handling CMC related health authority queries.
Regional Trends: Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
Marketing Authorization Applications: Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products (Orals & Parenterals) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
Variation Procedures: Preparation of documentation for different types of Variation procedures like Super grouping, Grouping and Work-sharing to the Marketing Authorizations.
Regulatory Review: Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.
Change Management: Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissions.
Cross-functional Collaboration: Liaise closely with cross-functional members with aligned product responsibilities.
Submission Management: Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
Safety Variations: To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates.
Regulatory Information Management Systems: Working experience in Regulatory Information Management Systems like Veeva Vault.
Communication Skills: Strong communications skills and ability to guide and mentor team members.
Independence: Ability to work independently.
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Raipur |Delhi :
Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | 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 :
Kochi | Malappuram |Madhya Pradesh :
Indore |Maharashtra :
Amravati | Aurangabad | Kolhapur | Mumbai | Nagpur | Navi Mumbai | Pune | 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 :
Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata |Arizona :
Chandler | Tempe | Tucson |California :
Davis | Emeryville | Foster City | La Jolla | Los Angeles | Pasadena | Riverside | San Diego | San Francisco | San Gabriel | Santa Clara | Santa Monica | Stanford |Colorado :
Denver |Connecticut :
Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Jacksonville | Tallahassee |Georgia :
Atlanta |Illinois :
Abbott Park | Champaign | Chicago | Deerfield |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |Maryland :
Baltimore | 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 | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Titusville | Warren Grove | West Orange | Westfield | Whippany |New York :
Buffalo | Ithaca | Morningside Heights |North Caroline :
Chapel Hills | Durham | Morrisville | Raleigh |Ohio :
Columbus, |Pennsylvania :
Philadelphia | Pittsburgh |Tennessee :
Nashville |Texas :
Austin | Houston |Virginia :
Blacksburg |Washington :
Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
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 |New South Wales :
Sydney |Queensland :
Queensland |United Kingdom :
London |Denmark :
Copenhagen |Serbia :
Belgrade |Republic of Ireland :
Dublin | Limerick |Remote :
Remote, USA | Remote - Europe | Remote | Switzerland |Makkah :
Najran | Jeddah |