Remote Pharma Regulatory Affairs Manager | Submissions

Placements24; South Africa; À distance; ZAR 700 000 - 1 300 000; Plein temps

Résumé du poste

Thermo Fisher Scientific seeks a Principal Regulatory Affairs Specialist to lead global regulatory submissions for clinical trials, coordinating with sponsors and agencies across multiple regions. The role focuses on ensuring compliance of CTAs, MAAs, and related documents while guiding internal teams on regulatory strategy.

Remote work with global scope is possible. You will drive submission initiatives, manage project teams, and participate in regulatory agency meetings to accelerate product

Qualifications

• Bachelor's or advanced degree in a relevant field or equivalent formal qualification.
• 8+ years' experience in global regulatory affairs for clinical trials.
• Knowledge of ICH/global regulatory guidelines and CTAs/MAA submissions.

Responsabilités

• Lead/global regulatory submissions for Phase 1–4 trials (CTA/MAA/NDA).
• Coordinate with sponsors and regulatory agencies; provide guidance.
• Review regulatory documents and literature; ensure compliance.
• Participate in launch and project meetings; lead defense discussions.

Connaissances

global regulatory submissions

sponsor interaction

regulatory document review

literature review

Formation

Bachelor's or advanced degree

Outils

Microsoft Word

Excel

PowerPoint

Description du poste

• What Pharma Regulatory Affairs Manager Submiss...

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Principal Regulatory Affairs Specialist (Global Clinical Trial Applications)

Remote ThermoFisher Scientific

Posted 11 days ago

Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
We are currently seeking a Principal Regulatory Affairs Specialist to join our global Regulatory Affairs department, Reg Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.
In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects.
You will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance.
You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients.
You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings.
**The following skills are required to be successful in this position:**

• preparation and assembly of global regulatory submissions (CTA)
• interacting with sponsors,
• review and assess clinical trial regulatory documents,
• review and assess scientific literature.
• manages project teams and preparation
• participate in launch meetings, review meetings and project team meetings.
• Experience with bid defense meetings

**Qualifications**
What the role requires you to have:

• Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 8+ years
• Knowledge of the global clinical trials landscape

**Knowledge, Skills and Abilities:**

• Excellent command of the English language (written and oral) as well as local language where applicable
• Experience with Bid Defense meetings
• Experience in leading global regulatory projects for Clinical Trial Applications
• Excellent attention to detail and quality as well as excellent editorial/proofreading skills
• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Strong organizational, time management, and planning skills to create and follow timelines, conduct long‑range planning, adapt to changing priorities and handle multiple projects
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
• Excellent analytical, investigative and problem‑solving skills

**What we offer:**
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award‑winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well‑being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work‑life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

About the Role Our client, a global pharmaceutical organization dedicated to advancing healthcare, is looking for a proactive and knowledgeable Remote Regulatory Affairs Specialist to support their South African operations. This position, based remotely but connected to our Kimberley, Northern Cape presence, is crucial for ensuring compliance with national and international regulatory requirements for pharmaceutical products. The ideal candidate will have a thorough understanding of regulatory submission processes, labeling, and post‑market surveillance. This remote role offers flexibility and the chance to contribute to bringing vital medicines to patients worldwide, working from the convenience of your home office. Key Responsibilities

• Prepare, review, and submit regulatory filings (e.g., CTX, MAA, NDA amendments) to health authorities like SAHPRA.
• Ensure all promotional materials and product labeling comply with regulatory guidelines.
• Maintain regulatory compliance for existing product registrations.
• Liaise with regulatory agencies and provide timely responses to inquiries.
• Conduct regulatory intelligence activities to stay abreast of evolving regulations.
• Provide regulatory guidance and support to internal teams, including R&D, marketing, and manufacturing.
• Manage post‑