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Full-time
Posted 1d ago
~40 hrs/week
Remote in Hyderabad, Telangana, India
Responsibilities
The Regulatory Affairs Associate will manage post-approval regulatory activities, including lifecycle management, CMC documentation updates, and regulatory submissions. They will perform impact assessments for change controls and ensure compliance with European regulatory requirements.
Requirements
The candidate must have at least 3 years of experience in post-approval regulatory activities for medicinal products registered through European procedures. Proficiency in managing regulatory dossiers and conducting gap analysis is essential for this role.
Full job description
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
We are seeking a detail-oriented Regulatory Affairs Specialist with 3+ yrs experience in post-approval regulatory activities for medicinal products registered through European procedures (CP, MRP, DCP, and National Procedures). The successful candidate will support lifecycle management activities, regulatory submissions, CMC documentation updates, and health authority interactions while ensuring compliance with applicable regulatory requirements.
Key Responsibilities
Perform Regulatory Impact Assessments (RIA) for Change Controls raised in TrackWise.
Assess regulatory implications of manufacturing, quality, labeling, and product information changes.
Manage and maintain regulatory change records within Veeva RIMS.
Support implementation of regulatory strategies for post-approval changes.
Review, update, and author Module 3 sections of CTD dossiers for medicinal products.
Ensure CMC documentation remains current and compliant with regulatory expectations.
Support dossier lifecycle maintenance activities across multiple markets.
Conduct comprehensive Gap Analysis of Module 3 documentation.
Identify compliance risks, data gaps, and documentation deficiencies.
Develop and recommend remediation plans and regulatory strategies to address identified gaps.
Manage post-approval regulatory activities throughout the product lifecycle.
Support maintenance of marketing authorizations across EU markets.
Collaborate with cross-functional teams to ensure timely execution of regulatory commitments.
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 22,000+ global employees work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award.
Community Guidelines
Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are:
• Abusive, harassing or threatening to others.
• Defamatory, offensive, obscene, vulgar or depicting violence.
• Hateful targeting by race/ethnicity, age, color, creed, religion, gender,
sexual preference or orientation, nationality or political beliefs.
• Sexually explicit or pornographic.
• Fraudulent, deceptive, libelous, misleading or unlawful.
• Referencing criminal or illegal activity.
• Spamming.
We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
Offices: 541 Church at North Hills St, 1000, Raleigh, North Carolina 27609, US
Regulatory and product development consultingearly phase clinical researchphase II-III clinical researchlate phase clinical researcheClinical solutionspatient and site recruitmentmedical device consultingclinical research organizationpharmacovigilancebiotechnology
How many Healthcare jobs are open in Hyderabad, India right now?
There are currently 1,570 open healthcare positions in Hyderabad, India listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Hyderabad, India?
Companies currently hiring include Amgen, The Cigna Group, Cigna Healthcare, MSD, Medtronic, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Hyderabad, India?
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