Biosimilar Product Regulatory Specialist

2 days ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 1,80,00,000

**Regulatory Affairs Specialist: Emerging Markets Role**

We are seeking a skilled Regulatory Affairs Specialist to join our team in managing regulatory activities for biosimilar products in the emerging market, with a strong focus on LATAM region.

This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in emerging markets.

Key Responsibilities:
  • Develop and implement regulatory strategies for biosimilar products in LATAM, staying up-to-date with local regulations and guidelines.
  • Prepare, review, and submit dossiers for marketing authorization applications (MAAs), renewals, and variations, ensuring compliance with local requirements.
  • Evaluate and implement regulatory changes impacting product lifecycle, maintaining accurate records and reporting updates to relevant stakeholders.
  • Manage post-approval activities including labeling updates, renewals, and change control assessments, ensuring seamless product delivery.
  • Ensure compliance with regional regulations and company SOPs, conducting regular audits and implementing corrective actions as needed.
  • Maintain up-to-date knowledge of LATAM regulatory guidelines, including Module 1 (m1) requirements for submissions.
  • Liaise with local health authorities, business partners, and internal teams, fostering effective communication and collaboration.
  • Support agency meeting preparations and GMP certification processes, ensuring timely completion and accuracy.
  • Assess regulatory impact of manufacturing and quality changes, developing strategic plans to address any issues.
  • Define submission plans and timelines for change control activities, ensuring efficient project execution.

Requirements:

To succeed in this role, you will need:

  • A minimum of 4 years' experience in Regulatory Affairs within the pharmaceutical/biotech industry.

Benefits:

You will enjoy a challenging and rewarding work environment, opportunities for professional growth and development, and a competitive compensation package.

Others:

Please note that this is a unique opportunity to join our dynamic team and contribute to the success of our organization.

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