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.
Senior Regulatory Affairs Consultant- CMC Biologics
Extensive experience in managing new registrations, life cycle maintenance, and renewals for biological products including vaccines, recombinant proteins, monoclonal antibodies, and plasma‑derived therapies across major markets such as the US, EU, Japan, Canada, Switzerland and Australia.
Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
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.
Strong communication and collaboration skills, ability to work independently.
The role is for a team lead with expectations to guide/mentor team members on technical aspects including regulatory filings to global markets
Experience level: 10 to 14 years of relevant experience
Location: India Remote
Education:
Minimum of a bachelor’s degree in a Scientific or Technical Discipline, Advanced Degree preferred
Skills Required
- 10 to 14 years of relevant Regulatory Affairs experience
- Bachelor's degree in a Scientific or Technical Discipline
- Advanced degree (preferred)
- Extensive experience managing new registrations, lifecycle maintenance, and renewals for biological products (vaccines, recombinant proteins, mAbs, plasma-derived therapies) across US, EU, Japan, Canada, Switzerland, Australia
- Preparation and delivery of regulatory submissions from global and regional perspectives, including authoring where relevant
- Preparation and review of Marketing Authorization Applications and Variations for US, EU, Japan, Canada, Switzerland, Australia
- Good understanding of regulatory frameworks, regional trends, and global pharmaceutical legislation/guidance linked to regulatory CMC aspects in ICH countries
- Strong communication and collaboration skills
- Ability to work independently
- Team lead experience with ability to guide and mentor team members on technical/regulatory filing aspects
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. 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.
