Senior Regulatory Affairs Associate - Biologics

Senior Regulatory Affairs Associate - Biologics

Overview

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.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel? Communicator, detail-oriented, problem-solver, relationship-builder, results-driven, strategic.

About This Role

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role

We are seeking a Senior Regulatory Affairs Associate - Biologics to join our team in a remote capacity in India. In this role, you will contribute to the life-cycle management of approved drug products, including small molecules and biologics such as vaccines and monoclonal antibodies, across global markets. You will help prepare and deliver regulatory maintenance submissions, author and review Chemistry, Manufacturing, and Controls content, respond to Health Authority requests, and support compliant post-approval activities across the EU, US, and other markets. You will join a collaborative, growth-oriented environment where your regulatory expertise supports the continued availability and compliant maintenance of important therapies. Through increasingly complex submissions, cross-functional partnership, and exposure to multiple markets and procedures, you will have opportunities to deepen your regulatory knowledge and broaden your impact within clinical research and development.

Key Responsibilities

• Contribute to the preparation, authoring where relevant, and delivery of simple regulatory maintenance submissions and, with experience, increasingly complex submissions from a global and regional perspective. Author and review Chemistry, Manufacturing, and Controls components of Marketing Authorization Applications and variations for oral and parenteral medicinal products filed in the EU through Decentralised, Mutual Recognition, and National Procedures. Prepare documentation for variation procedures, including Super Grouping, Grouping, and Work-Sharing applications for Marketing Authorizations. Handle Chemistry, Manufacturing, and Controls related Health Authority queries and author responses to Health Authority requests. Review Drug Master Files, batch records, specifications, and stability data for compliance with applicable regulatory requirements. Author Chemistry, Manufacturing, and Controls components of Annual Reports, renewals across Modules 1, 2, and 3, and Good Manufacturing Practice related submissions, including site registrations. Provide regulatory impact assessments for change controls and identify documentation required for EU, US, and other market submissions. Prepare, review, and submit safety variations to Health Authorities and complete post-approval Chemistry, Manufacturing, and Controls updates. Execute and maintain submission delivery plans and submission content plans, and proactively provide status updates to designated stakeholders. Liaise closely with cross-functional teams and stakeholders to maintain alignment on product-related responsibilities. Author and maintain labeling content for the EU, US, Canada, and Australia and New Zealand markets based on the Company Core Data Sheet, Pharmacovigilance Risk Assessment Committee recommendations, and Coordination Group for Mutual Recognition and Decentralised Procedures recommendations.

• Required Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline. 5+ years of experience in the life-cycle management of approved drug products, including small molecules and biologics such as vaccines and monoclonal antibodies, across global markets. Experience authoring and reviewing Chemistry, Manufacturing, and Controls components of Marketing Authorization Applications, variations, Annual Reports, renewals, and Good Manufacturing Practice related submissions. Experience handling Chemistry, Manufacturing, and Controls related Health Authority queries and authoring responses.

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• Why Consultants work at Parexel

• Patient-led in everything we do

• We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects.

• Supportive and inclusive environment

• We thrive on collaboration, caring, and inclusivity - enabling our people to work together to solve complex problems and share knowledge.

• Opportunities for career growth

• We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth.

• Flexible work arrangements

• We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our We Care team environment.

• Diverse and global client exposure

• We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development and approval.

• Learn from experts

• You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills and advance in your career.

• Learn About Our Culture

• Cell and Gene

• Our Cell and Gene Therapy Center of Excellence (COE) integrates regulatory expertise with a cross-functional team to get treatments to market faster.

• General Medicine

• Our general medicine thought leaders provide innovative development strategies and principled trial design and conduct across the following indications: Cardiovascular, Endocrinology and metabolism, Nephrology and genito-urinary, Respiratory, and Women’s health.

• Hematology

• Our specialists in hematology have long been at the cutting edge of innovations, treating patients participating in clinical trials from first-in-human to post-market studies across the indications of Lymphoma, Acute myeloid leukemia (AML), Myelodysplastic syndrome (MDS), Multiple myeloma, Benign and malignant disorders.

• Infectious Disease and Vaccines

• Our infectious disease team is built upon the global experience and public health knowledge that drives research within these indications: Hepatitis B, Bacterial indications, Vaccines, preventative, and treatment, Critical care, Long COVID syndrome.

• Inflammation and Immunology

• Our broad knowledge of the underlying mechanisms of diseases, paired with medical expertise and global operations, enable us to support demands in Allergy/immunology, Dermatology, Gastroenterology, Ophthalmology, and Rheumatology.

• Neuroscience

• Enormous advances in the understanding of how the brain works and development of treatment modalities are cause for great hope for millions of people affected by neurological disorders. Our expertise covers all indications across neurology and psychiatry.

• Oncology

• We support treating all major types of cancer, across every phase of development, and the following indications: Benign and malignant hematology, Breast and gynecological cancers, Gastrointestinal cancers, Genitourinary cancers, Lung and head-and-neck cancer, Phase I and rare tumors.