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Premier Research Group

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4.4

based on 17 Reviews

4 Premier Research Group Jobs

Regulatory Start up Manager

Premier Research

4.4

based on 17 Reviews

2-6 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Regulatory Start up Manager

Premier Research Group

posted 6d ago

Job Role Insights

Flexible timing

Key skills for the job

Biotechnology Pharmacy Software Configuration Management Clinical Research GCP Continuous Improvement

Job Description

Premier Research is looking for a Regulatory Start up Manager to join our Global SSU team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
We are Built by You. Your ideas influence the way we work, and your voice matters here.
We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech . Join us and build your future here.

What youll be doing:

Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules in the assigned countries. Expertise in India is required.

As India country expert, performs country specific tasks associated with the start-up of a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements.

Provides regulatory support for clinical trial applications, which includes investigational new drug applications and clinical trial applications, and ongoing trials and post approval activities. In addition, the role is responsible for working with cross-functional teams to manage the preparation, review, and assembly of regulatory submissions to Indian Health Authority (DCGI/CDSCO) contributes to regulatory strategy, identifying risks and opportunities, while leading both simple and complex regulatory applications and managing procedures through approval.. This position also supports the client project team that authors and reviews all materials required in submissions and interacts with regulatory agencies.
Direct Experience in National Single Window System management.
Prepare submissions and oversee the maintenance of regulatory filings to support multinational and local trials (i.e., INDs, CTAs, amendments, safety updates, and Annual Reports) as well as Ethics Committee /IRB submission, import and export licenses and any additional board/evaluating body required to obtain study approval that allow the conduct of clinical research within the country required.
Review clinical trial submission documents including clinical protocols/reports, investigator brochures and nonclinical reports
Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input. Responsible for identifying & communicating country timelines to project teams and client (as applicable) . Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, escalates the problem as soon as identified and provides suggestions for resolution.
Execute regional strategy and contingencies for assigned projects.
Liaise with regulatory agency project manager in coordinating meetings, providing responses to agency questions/requests.
Lead the preparation of submissions, which may include INDs CTAs, and briefing documents, review master IP labels and provides feedback on its potential acceptability to regulatory authorities including issues related to country adaptation
Coordinate with cross-functional teams to define contributions to submissions.
Maintain knowledge of regulatory environment, regulations, and guidelines.
Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level

In addition to the above, this role will be involved in country start up activities coordination, such as:

Site feasibility and identification
Country applicable registries (CTRI)
IRB submissions
Production and/or review submission components like the Patient Information Form/ICF.
Oversees the site contract execution process in the assigned countries
Oversees the regulatory approval of IP release

The RSM collaborates with project team members in other functional areas to ensure delivery within contractual obligations. The RSM is accountable for delivery of startup activities at the project level.

The RSM maintains a proactive, positive, results-oriented work environment.

What we are looking for:

Education to university degree level (pharmacy, medicine or related natural sciences are a plus)
Minimum of 5 years professional experience in the clinical research area, in Regulatory and/or Start-up functions at a local/country level, for newly awarded Studies containing countries from the same region, and may take a multi-region study in Start-up under supervision, or maintenance studies independently.
At least 2 years of hands-on experience in the submission of clinical trial applications
Knowledge of ICH / GCP regulations / country specific regulations as applicable
Ability to work accurately and to interpret the relevant directives and guidelines
Working knowledge of professionally recognized tools for planning and management of scope, timeline, resources, and budget
Strong verbal and written communication and negotiation skills

Employment Type: Full Time, Permanent

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