Key Facts

Remote From:

India

Category: Regulatory Affairs Manager

Full time

Senior (5-10 years)

English

Hard Skills

Regulatory Compliance Reference Management Mock Ups Clinical Documentation Safety Standards Scientific Document Preparation Cross-Functional Collaboration Training Analysis

Other Skills

•
Communication

Roles & Responsibilities

Experience submitting labeling and safety variations in EU countries including the UK and Ireland
Proficiency in preparing and reviewing M1 documents (Cover letter, eAF, mock-ups, Clinical Overview, Literature References)
Experience handling MRP and EU national procedures; updating labeling documents (SmPC, PIL) and coordinating artwork updates
Veeva experience for tracking submissions, updating status, and creating HAQs; strong communication and cross-functional team coordination

Requirements:

Submitting labelling and safety variation applications in EU countries including the UK and Ireland
Preparation and review of M1 documents – Cover letter, eAF, Mock-ups, Clinical Overview, Literature References
Handling MRP and EU national procedures; updating the labelling impacted documents (SmPC, PIL) and coordinating artwork updates
Maintaining Veeva-based submission tracking, updating submission status, creating HAQs; HA correspondence and monitoring agency websites for approved information

Parexel

Pharmaceuticals

About Parexel

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.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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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.

Senior Regulatory Affairs Associate

Submitting labelling / safety variations in EU countries including UK and Ireland
Preparation and review of M1 documents – Cover letter, eAF , Mock-ups, Clinical Overview, Literature References
Handled MRP and National procedures in EU
Updating the labelling impacted documents - SmPC, PIL and/or Label
Artwork update coordination
Veeva experience with tracking submissions, updating status, creating HAQ’s
Excellent communication and CFT coordination.
HA correspondence and checking agency websites for approved information