Regulatory Affairs Consultant – Remote, India
Location: India (Remote)
Job Category: Regulatory Affairs / Life Sciences / Biopharmaceutical Consulting
Employment Type: Full-Time, Permanent
About the Role
Parexel is seeking an experienced Regulatory Affairs Consultant to join our global consulting team. In this role, you will leverage your scientific, technical, and regulatory expertise to guide biopharmaceutical and medical device companies through complex regulatory requirements, enabling faster product approvals and successful lifecycle management.
This position offers exposure to diverse global markets, including the US, EU, Japan, Canada, Switzerland, and Australia, and involves collaboration with cross-functional teams, clients, and regulatory authorities. The role is remote, allowing flexibility while maintaining engagement with a dynamic and supportive global team.
Key Responsibilities
Lead preparation, review, and delivery of regulatory submissions for new registrations, lifecycle management, and renewals of biologicals, vaccines, recombinant proteins, monoclonal antibodies, plasma-derived products, and small molecules.
Author, compile, and submit Marketing Authorization Applications (MAAs) and variations across global and regional markets.
Provide strategic regulatory guidance for Chemistry, Manufacturing, and Controls (CMC) aspects in compliance with ICH guidelines and regional regulations.
Monitor and interpret regulatory trends across multiple markets, ensuring submissions align with evolving requirements.
Collaborate effectively with clients, internal teams, and external stakeholders to resolve regulatory challenges and optimize submission strategies.
Maintain accurate documentation and ensure compliance with corporate SOPs, regulatory standards, and quality expectations.
Required Skills & Competencies
In-depth knowledge of global regulatory frameworks, including region-specific submission processes for small and large molecules.
Strong expertise in regulatory strategy, CMC documentation, and lifecycle management.
Excellent communication, collaboration, and stakeholder management skills.
Ability to work independently, manage multiple projects, and deliver high-quality results under tight deadlines.
Strategic thinking with problem-solving capabilities and attention to detail.
Experience & Qualifications
Experience: Minimum 6 years in regulatory affairs, including handling submissions for biologicals, vaccines, monoclonal antibodies, recombinant proteins, plasma-derived products, or small molecules in global markets.
Demonstrated experience in regulatory submissions across US, EU, Japan, Canada, Switzerland, and Australia.
Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related field. Advanced degrees or professional certifications in regulatory affairs are advantageous.
Why Join Parexel?
Global exposure: Work with international clients and regulatory authorities across multiple regions and therapeutic areas.
Professional growth: Engage in challenging assignments, mentorship, and continuous learning opportunities.
Remote flexibility: Contribute to impactful projects while working remotely from India.
Supportive culture: Collaborate with a team that values inclusion, innovation, and patient-centered solutions.
Advance your career as a Regulatory Affairs Consultant and play a pivotal role in guiding life-changing therapies to patients worldwide.
Uttar Pradesh :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | Renfrew | Mississauga | Richmond Hill | North York | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv | Yavne |Remote :
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Ciudad de México | New Mexico |Dubai :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
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Sofia |Sweden :
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Warsaw |
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