Regulatory Consultant (CMC-EU, GCC & AU)

Accountabilities: Independently manage regulatory activities for both standard and complex submissions, ensuring alignment with global and regional regulatory requirements.

Conduct regulatory research and gap analyses to support product development strategies, regulatory plans, and submission preparation.

Prepare and contribute to administrative and technical components of regulatory submissions, including pre-approval applications, product registrations, lifecycle management activities, and post-approval updates.

Support preparation of briefing documents, agency meeting materials, and regulatory interactions with health authorities.

Manage daily regulatory project activities according to agreed timelines, scope, budgets, and strategic objectives.

Provide regulatory expertise within multidisciplinary project teams, collaborating with clinical and technical specialists throughout the product lifecycle.

Act as a subject matter expert by identifying challenges, providing solutions, and supporting project teams with regulatory guidance.

Develop regulatory service estimates and contribute to proposals, client discussions, and business development activities.

Ensure compliance with applicable global regulations, internal procedures, quality standards, and regulatory best practices.

Create training materials, share regulatory knowledge, and support continuous improvement initiatives.

Participate in audits, internal cross-functional projects, SOP development, and process documentation activities.

Provide guidance and oversight to team members when required, ensuring effective execution of regulatory responsibilities.

Requirements:

Proven experience in regulatory affairs, particularly in Chemistry, Manufacturing, and Controls (CMC) regulatory activities across global markets.

Strong understanding of regulatory submission processes, product registrations, lifecycle management, and health authority interactions.

Experience supporting regulatory activities within European Union, GCC, and Australian markets is highly desirable.

Ability to analyze regulatory requirements, identify gaps, and develop practical strategies for successful submissions.

Experience working with multidisciplinary teams in pharmaceutical, biotechnology, or life sciences environments.

Strong knowledge of global regulatory guidelines and compliance expectations.

Excellent project management skills with the ability to manage multiple priorities, timelines, and stakeholders.

Strong written and verbal communication skills, with the ability to prepare regulatory documents and present recommendations clearly.

Ability to act as a trusted regulatory advisor and provide solutions to complex challenges.

Experience preparing proposals, supporting client interactions, and contributing to business development activities is a plus.

Strong attention to detail, analytical thinking, and commitment to quality standards.

Benefits:

Fully remote work opportunity from India with flexibility depending on business requirements.

Opportunity to contribute to global healthcare projects and support the development of life-changing therapies.

Exposure to international regulatory environments and complex product development programs.

Collaboration with experienced professionals across clinical, technical, and regulatory disciplines.

Career development opportunities through training, mentorship, and continuous learning programs.

Inclusive and collaborative workplace culture focused on innovation and meaningful impact.

Opportunities to expand expertise across diverse therapeutic areas and regulatory projects.

Competitive rewards and benefits package.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether? 

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