Are you a regulatory professional looking for a challenging role in a globally renowned biopharmaceutical consulting company? Parexel is seeking a Regulatory Affairs Consultant to help clients navigate the intricate regulatory landscape and bring their products to market efficiently.
About Parexel
Parexel is a leading global provider of biopharmaceutical services. With a focus on innovation and client success, Parexel offers expertise in regulatory, clinical, and commercial services. The company values collaboration, continuous learning, and empowering employees to deliver excellence.
As a Parexel consultant, you will work on diverse product types and therapeutic areas, partnering with a wide range of clients to develop and implement effective regulatory strategies.
Key Responsibilities
In this role, you will:
- Manage the lifecycle of approved drug products (e.g., Tablets, Syrups, Ointments, Nasal Sprays) for Rest of the World (ROW) markets.
- Apply your knowledge of ROW regulatory guidelines, including post-approval requirements, to deliver high-quality outcomes.
- Handle CMC (Chemistry, Manufacturing, and Controls) and labeling-related health authority queries.
- Strategically plan, prepare, and review minor and safety labeling variations across ROW countries.
- Contribute to regulatory maintenance submissions from a global or regional perspective, ensuring compliance and timely delivery.
- Utilize tools like Veeva Vault for Regulatory Information Management and Vista Link for Artwork Management.
- Collaborate with cross-functional teams, providing proactive status updates to stakeholders.
- Exhibit strong communication and problem-solving skills to work independently without supervision.
Qualifications and Skills
To thrive in this role, candidates should meet the following criteria:
- Experience: 8+ years in regulatory affairs, with expertise in managing approved drug products for ROW markets.
- Knowledge: Familiarity with regulatory legislations of ROW and ASEAN markets is an added advantage.
- Technical Skills: Experience with Regulatory Information Management Systems (Veeva Vault) and Artwork Management Tools (Vista Link).
- Soft Skills: Strong listening, communication, and relationship-building abilities.
- Independence: Ability to work autonomously and deliver results without supervision.
