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Promea Therapeutics

Regulatory Affairs Manager

Promea Therapeutics
Hyderabad, India
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  • Posted 2 months ago
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Job Description

Job Responsibilities

  • Regulatory Strategy Development
  • Identifying the most efficient regulatory pathway for drug approval.
  • Preparing a comprehensive plan to comply with international regulatory requirements.
  • Advising on timelines, documentation, and submission requirements.
  • Understanding the nuances of different regulatory bodies is crucial for developing strategies that minimize delays and maximize approval success.
  • Preparation and Submission of Regulatory Documents
  • A core responsibility of DRA professionals is preparing, reviewing, and submitting regulatory documents to authorities.
  • Attention to detail and knowledge of submission platforms, such as CTD (Common Technical Document), are essential.
  • Liaising with Regulatory Authorities
  • Responding to queries and requests for additional information.
  • Attending meetings with regulatory agencies to discuss the drug development process.
  • Ensuring compliance with post-approval changes and modifications.
  • Building strong relationships with regulatory agencies helps facilitate smoother approval processes.
  • Monitoring Regulatory Compliance
  • Conducting periodic audits and inspections.
  • Managing post-market surveillance activities.
  • Reviewing and submitting periodic safety update reports (PSURs).
  • Ensuring compliance with pharmacovigilance and adverse event reporting.
  • Staying updated on regulatory changes and proactively managing compliance
  • Labeling and Advertising Compliance
  • Reviewing and approving product labels, ensuring accurate information.
  • Ensuring that advertising and marketing materials meet legal and ethical standards.
  • Addressing labeling updates required by regulatory agencies.
  • Risk Management and Mitigation
  • Identify and assess potential risks associated with pharmaceutical products.
  • Develop strategies to mitigate these risks.
  • Monitor and evaluate the effectiveness of risk management strategies.
  • Domestic Regulatory Activates
  • Uploading the documents on SUGAM portal and on the portals of other State Regulatory Authorities.
  • Handling and responding to all the product specific queries to the related drug departments.
  • Ensuring overall compliance to domestic regulatory requirements.
  • Co-ordination with respective departments.
  • Maintaining familiarity with company product ranges.
  • Keeping up to date with changes in regulatory legislation and guidelines.
  • Ensuring that quality standards are met and submissions meet strict deadlines.
  • Maintain high levels of accuracy, meet tight deadlines.

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Pharmaceutical
Employment Type:
Full time

About Company

Promea Therapeutics

Job ID: 144673169

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Last Updated: 24-05-2026 05:49:39 PM
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Regulatory Affairs Manager

Promea Therapeutics
Hyderabad, India

Skills:

SUGAM portal, Adverse Event Reporting, CTD Common Technical Document, Pharmacovigilance, Regulatory Strategy Development, Regulatory Compliance, Risk Management