Parexel Hiring Regulatory Affairs Associate Remote Job in India with remote options. Apply now for global CRO regulatory jobs in pharma industry 2026.
Introduction
Global clinical research organization Parexel has announced a new opportunity for skilled regulatory professionals in India. The company is hiring a Regulatory Affairs Associate to support international regulatory submissions and lifecycle management activities. This role is ideal for candidates with experience in CMC regulatory affairs and a strong understanding of global submission frameworks, particularly in EU markets. If you are looking to grow your regulatory career in a multinational environment, this role offers exposure to global health authorities and high-impact projects. Parexel Hiring Regulatory Affairs Associate Remote Job
Company Overview
Parexel is a globally recognized Clinical Research Organization (CRO) known for delivering innovative drug development and regulatory consulting services. The company partners with pharmaceutical, biotechnology, and medical device organizations to accelerate the development and approval of new therapies. With a strong presence across continents, Parexel plays a critical role in clinical trials, regulatory strategy, and market access initiatives, ultimately contributing to improved patient outcomes worldwide.
Job Location & Employment Type
- Location: India (Bengaluru / Hyderabad / Remote options available)
- Employment Type: Full-time
- Work Model: Hybrid / Remote flexibility depending on location
- Shift Requirement: EU shift alignment required
Department Details
- Role: Regulatory Affairs Associate
- Domain: Regulatory Affairs – CMC (Chemistry, Manufacturing, and Controls)
- Industry: Clinical Research / Pharmaceutical Services
- Hiring Mode: Direct company recruitment
Key Roles & Responsibilities
The Regulatory Affairs Associate will be responsible for supporting global regulatory submissions and lifecycle activities, particularly for EU regulatory markets. The selected candidate will work closely with cross-functional teams and ensure compliance with evolving regulatory guidelines. Parexel Hiring Regulatory Affairs Associate Remote Job
Core responsibilities include:
- Understanding regional and global regulatory frameworks across various submission types and therapeutic areas
- Supporting regulatory strategies for small and large molecule products
- Providing regulatory guidance on procedural and documentation requirements
- Reviewing and evaluating regulatory documents before submission
- Contributing to submission planning and delivery strategies
- Analyzing regulatory pathways, special designations, and submission routes
- Preparing and authoring dossier sections based on updates to approved MAA dossiers
- Coordinating with internal teams such as clinical, CMC, and regulatory stakeholders
- Developing and maintaining submission timelines and content plans
- Monitoring submission progress and providing regular updates to stakeholders
- Evaluating product changes in line with regional regulatory guidelines
- Supporting lifecycle management activities in EU regulatory markets
- Reviewing dossiers and supporting submissions to health authorities
- Assisting in regulatory negotiations and responses to authority queries
- Collaborating with local regulatory and commercial teams to assess regulatory impact
Parexel Hiring Regulatory Affairs Associate Remote Job
Eligibility Criteria
Education
Candidates from the following academic backgrounds are preferred:
- B.Pharm / M.Pharm
- MSc in Life Sciences, Biotechnology, or related discipline
- Other relevant pharmaceutical or scientific degrees
Experience
- Relevant experience in Regulatory Affairs, preferably in CMC domain
- Prior exposure to EU regulatory markets is highly desirable
- Experience with lifecycle management activities will be an advantage
- Familiarity with global submission standards is preferred
Skills Required
- Strong understanding of global regulatory frameworks
- Knowledge of EU regulatory submission processes
- Familiarity with MAA lifecycle management
- Excellent documentation and dossier review skills
- Ability to analyze regulatory guidelines and procedural requirements
- Strong project coordination and stakeholder communication skills
- Ability to work in global shifts and cross-functional teams
- Attention to detail and compliance-focused mindset
Salary & Benefits
- Compensation: As per company norms
- Additional benefits may include performance incentives, global exposure, and career development opportunities typically offered by multinational CROs.
Selection Process
The recruitment process generally includes:
- Application screening
- HR discussion
- Technical / functional interview rounds
- Final selection and offer rollout
(Exact process may vary depending on role requirements and candidate experience.) Parexel Hiring Regulatory Affairs Associate Remote Job
How to Apply
Interested candidates should apply through the official Parexel careers portal using the job requisition ID provided in the listing. Ensure your resume highlights regulatory CMC experience and international submission exposure for better chances of selection. Parexel Hiring Regulatory Affairs Associate Remote Job
Important Dates
- Application Status: Open until positions are filled
(Candidates are advised to apply early due to competitive hiring.)
Why Apply for This Pharma Job?
Working with Parexel offers a unique opportunity to build a global regulatory career while contributing to life-changing therapies. This role provides exposure to international regulatory frameworks, collaboration with global teams, and involvement in high-impact regulatory submissions. Professionals seeking long-term growth in regulatory affairs will benefit from Parexel’s structured career pathways, global learning environment, and involvement in cutting-edge pharmaceutical innovations. Parexel Hiring Regulatory Affairs Associate Remote Job
Important Note
IndiaPharmaJobs.in is an independent job information platform created to help job seekers find the latest pharmaceutical and healthcare career opportunities. We are not affiliated with Parexel or any hiring organization. Candidates are advised to verify details on the official company website before applying. Parexel Hiring Regulatory Affairs Associate Remote Job
Final Words
If you have regulatory affairs experience and want to work in a globally respected CRO, this Parexel opportunity could be your next big career move. Apply as soon as possible and take a step toward advancing your regulatory career in the international pharmaceutical landscape. Parexel Hiring Regulatory Affairs Associate Remote Job
