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Regulatory Affairs Consultant

8+ years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Affairs Consultant - Parexel Consulting

Job Overview
As a Regulatory Affairs Consultant within Parexel Consulting, you will play a critical role in guiding biopharmaceutical and medical device companies through the complex regulatory landscape. Using your expertise in science, technical knowledge, and regulatory affairs, you will work with clients to develop strategies that streamline the product approval process and maintain market presence.

You will be part of a collaborative and innovative team, working remotely while gaining exposure to diverse product types, therapeutic areas, and clients. Parexel supports continuous learning, offering opportunities for professional growth through challenging assignments and mentorship from experienced regulatory professionals.


Success Profile

The ideal candidate for this role will possess the following interpersonal traits and soft skills:

  • Communicator: Ability to clearly convey ideas and information to clients and internal teams.

  • Detail-oriented: Focused on accuracy and thoroughness in all tasks.

  • Problem-solver: Capable of identifying issues and developing effective solutions.

  • Relationship-builder: Able to develop and maintain strong relationships with clients and colleagues.

  • Results-driven: Focused on achieving goals and delivering outcomes.

  • Strategic: Able to think long-term and plan accordingly to achieve objectives.


About This Role

Experience Requirements:

  • 8+ years of experience handling the life cycle management of approved drug products (e.g., tablets, syrups, ointments, nasal sprays) for ROW (Rest of World) markets.

  • Strong working knowledge of ROW regulatory guidelines, including post-approval requirements.

  • Familiarity with ASEAN market regulations is a plus.

Responsibilities:

  • Lead and/or contribute to the planning, preparation (including authoring), and delivery of regulatory maintenance submissions from both global and regional perspectives.

  • Take charge of strategizing and preparing minor labelling variations and safety labelling variations across ROW countries in alignment with business needs.

  • Handle CMC (Chemistry, Manufacturing, and Controls) and labelling-related health authority queries efficiently.

  • Collaborate with cross-functional teams and stakeholders to provide regular status updates and ensure alignment.

  • Prior experience with Regulatory Information Management Systems (e.g., Veeva Vault) is desirable.

  • Familiarity with artwork management tools (e.g., Vista link) would be an added advantage.

  • Strong listening and communication skills are highly valued.

  • Ability to work independently without supervision, demonstrating initiative and reliability.


What Parexel Offers

  • Remote flexibility with a collaborative team culture.

  • Exposure to diverse markets and therapeutic areas.

  • Opportunities for professional growth and mentorship.

  • Challenging assignments to develop your regulatory expertise further.


About Parexel

Parexel is a global leader in providing outsourced services to the pharmaceutical, biotechnology, and medical device industries. Our Regulatory Affairs team plays a crucial role in accelerating product development and market access, ensuring compliance with global regulatory standards, and helping our clients bring their innovative products to market.


This role offers a great opportunity for professionals with extensive regulatory experience to contribute to the lifecycle management of products in dynamic international markets.