Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Change Risk Assessment Regulatory Compliance Regulatory Compliance Regulatory Compliance Product Renewals Safety Audits International Laws Applicant Tracking Systems Cross-Functional Collaboration Documentation Generation Training Analysis Global Management

Other Skills

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Safety Assurance
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Communication
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Planning
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Organizational Skills
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Detail Oriented

Roles & Responsibilities

5 to 8 years of experience in regulatory affairs
Strong knowledge of global regulatory guidelines and CTD/eCTD structure, especially Module 1
Experience in lifecycle management: renewals, variations, PSUR/PBRER submissions, label updates, and CMC changes
Familiarity with change control processes and regulatory impact assessments

Requirements:

Prepare, organize, and review country-specific regulatory documentation (Module 1, administrative forms, declarations) and manage local submissions (registrations, renewals, variations, PSURs/PBRERs, safety updates, label updates, and CMC changes); maintain local regulatory databases (VEEVA RIMS) and archives; ensure formatting and quality; liaise with global/regional RA for alignment
Provide local input for post-approval changes: evaluate change control notifications related to manufacturing, quality, safety, or labeling changes and assess regulatory impact; coordinate with global/regional RA, Quality, and Supply Chain; prepare and submit variation dossiers; track timelines and ensure timely fulfillment of regulatory commitments
Support audits and inspections: assist during internal and external audits and health authority inspections; coordinate and prepare documentation; respond to audit observations; collaborate with cross-functional teams to close CAPAs and maintain readiness of RA records
Maintain ongoing regulatory compliance and proactively identify potential regulatory risks in the local market; liaise with cross-functional teams to ensure alignment with evolving national regulations

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

The role is responsible for supporting end‑to‑end regulatory lifecycle management activities for assigned products in the local market. This includes preparation and maintenance of country‑specific regulatory documentation, coordination of post‑approval changes, and ensuring compliance with national regulatory requirements. The position also supports audits/inspections and collaborates with cross‑functional teams (Quality, Supply Chain, Pharmacovigilance, Medical, Commercial) to maintain regulatory compliance.

1. Preparation, Organization & Coordination of Local Regulatory Documentation

Prepare, compile, and review country‑specific regulatory documentation (e.g., Module 1, administrative forms, declarations, national templates) in accordance with local health authority requirements.
Support regulatory submissions including new registrations, renewals, variations, PSURs/PBRERs, safety updates, label updates, and CMC‑related changes.
Maintain and update local regulatory databases (VEEVA RIMS), tracking systems, and product registration archives to ensure compliance with local legislation.
Ensure that all documents meet formatting, quality, and content standards required for national submissions.
Liaise with global/regional RA teams to obtain submission components and ensure alignment with global dossiers.

2. Provide Local Input for Post‑Approval Changes & Change Control

Evaluate change control notifications related to manufacturing, quality, safety, or labelling changes and provide country‑specific regulatory impact assessments.
Work with global/regional RA, Quality, and Supply Chain teams to ensure timely implementation of post‑approval changes as per national regulatory timelines.
Prepare and submit variation dossiers or notifications based on local regulatory classifications and guidelines.
Track approval timelines and ensure that all regulatory commitments arising from changes are fulfilled promptly.

3. Support in Audits, Inspections & Regulatory Compliance

Support the local RA representative during internal audits, external audits, and health authority inspections.
Coordinate and prepare documentation required for inspections, ensuring readiness of RA records and systems.
Assist in responding to audit observations and regulatory findings.
Collaborate with cross‑functional teams to ensure timely closure of Corrective and Preventive Actions (CAPAs).
Ensure continuous compliance with evolving national regulations and proactively identify potential risks.

Key Skills & Competencies Required

Strong knowledge of global regulatory guidelines and understanding of the CTD/eCTD structure, especially Module 1.
Experience in lifecycle management: renewals, variations, PSUR/PBRER submissions, label updates, CMC changes.
Familiarity with change control processes and regulatory impact assessments.
Good documentation skills and attention to detail.
Ability to work effectively with cross‑functional and global teams.
Strong organizational, planning, and communication skills.
Prior experience with regulatory databases or submission‑tracking tools is an advantage.

Experience Level: 5 to 8 years

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