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Open nowPosted 431 days ago

425410 Regulatory Specialist Submission Co-ordinator (Open)

ScaleneWorks INC

Where
Bengaluru Luxor North Tower
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Your applicationOpen now425410 Regulatory Specialist Submission Co-ordinator (Open)ScaleneWorks INC · Bengaluru Luxor North Tower

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Share of postings closed within
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  2. 4.5%3 days
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  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: posted 431 days ago

The posting

425410 Regulatory Specialist Submission Co-ordinator (Open)

## Job Summary The Regulatory Specialist Submission Co-ordinator plays a crucial role in the pharmaceutical industry by ensuring compliance with regulatory requirements throughout the drug development process. This position is responsible for managing submissions related to marketing applications, pre-approval, investigational, and lifecycle maintenance, while adhering to timelines and regulatory guidelines.

## Responsibilities - Deliver Marketing Application, pre-approval/investigational, and lifecycle maintenance submissions in compliance with Regulatory Authority regulations and organizational SOPs. - Lead relevant submission teams for product regulatory authority submissions or maintenance activities associated with approved products, including renewals and site registrations. - Provide guidance to project teams and client groups on submission-related processes and content requirements for key markets. - Interact effectively with line and middle management, staff, and external contacts in a matrix environment. - Adapt to shifting priorities and timelines while maintaining a flexible approach to problem-solving. - Interpret regulations and ensure adherence to regulatory standards throughout the submission process.

## Qualifications - Awareness of the pharmaceutical industry, drug development environment, and R&D processes. - Knowledge of Regulatory Affairs responsibilities from pre-Investigational New Drug (IND) through Phases I-IV. - Strong communication and interpersonal skills to interact with various stakeholders. - Ability to think flexibly and manage multiple priorities effectively. - Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, or related discipline). - Experience in regulatory submissions and knowledge of regulatory guidelines.

## Preferred Skills - Familiarity with specific regulatory requirements for key markets. - Experience in leading cross-functional teams. - Proficiency in project management tools and methodologies.

## Experience - Relevant experience in regulatory affairs or submission coordination within the pharmaceutical industry is preferred.

## Environment - The position is based in Bengaluru, Luxor North Tower, and operates in a hybrid work mode, combining both in-office and remote work.

## Salary - Estimated salary range: ₹2,500,000 per annum.

## Growth Opportunities - Opportunities for career advancement within the regulatory affairs department and potential leadership roles in submission management.

## Benefits - Comprehensive benefits package including health insurance, paid leave, and flexible work policies.

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