Medical Regulatory Writer

Location India
Contact name: Christopher Blohm

Contact email: christopher.blohm@medella.life
Job ref: 783
Published: 9 months ago

Job Description:

Position Overview: As a Medical Regulatory Writer, you will play a crucial role in the regulatory affairs team, supporting our efforts to secure regulatory approvals for our pharmaceutical products. You will be responsible for creating high-quality regulatory documents that adhere to local and international regulatory requirements. This position offers an exciting opportunity to contribute to the success of our organisation by ensuring compliance and the timely submission of regulatory documents.

Key Responsibilities:

  1. Prepare Regulatory Documents: Develop and draft a wide range of regulatory documents, including but not limited to Clinical Study Reports (CSR), Investigator's Brochures (IB), and Module 2 sections of regulatory submissions.

  2. Compliance: Ensure that all regulatory documents meet local and international regulatory requirements and guidelines, such as those set by the Central Drugs Standard Control Organisation (CDSCO) and other relevant authorities.

  3. Cross-functional Collaboration: Collaborate closely with cross-functional teams, including regulatory affairs, clinical, and medical affairs, to gather necessary information and data for document preparation.

  4. Quality Assurance: Perform quality checks and proofreading to ensure accuracy, consistency, and compliance with company standards.

  5. Timely Submission: Assist in the preparation of regulatory submissions and ensure that all documents are submitted in a timely manner to meet regulatory deadlines.

  6. Documentation Management: Maintain accurate records and documentation related to regulatory writing projects.

  7. Regulatory Updates: Stay up-to-date with changes in local and international regulatory guidelines and incorporate them into document preparation.

Qualifications:

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.
  • Proven experience as a medical regulatory writer in the pharmaceutical industry.
  • Strong understanding of Indian regulatory requirements and guidelines.
  • Excellent written and verbal communication skills in English.
  • Attention to detail and the ability to work independently.
  • Proficiency in Microsoft Office Suite and document management tools.
  • Knowledge of International Conference on Harmonisation (ICH) guidelines is a plus.

Contract Details:

  • This is a contract position with a duration of 12 month.
  • The position is remote, allowing you to work from anywhere in India.