Regulatory Compliance Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeCompliance Full time

Job Summary:

A highly skilled Regulatory Compliance Change Assessor is required to review change records, evaluate the impact of changes on reportability and product restrictions, and ensure regulatory strategies are aligned across functions.

Key Responsibilities:

  • Evaluate the impact of changes on reportability and product restrictions for products in scope.
  • Define and document reporting and product distribution restriction requirements within the change control management system.
  • Collaborate with Process Development, Operations, Quality, and Supply Chain teams to ensure regulatory alignment.

Requirements:

  • Masters degree or equivalent experience in a related field.
  • Bachelors degree with 2 years of relevant experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry.
  • Associates degree with 6 years of relevant experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry.
  • Diploma with 8 years of relevant experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry.

Preferred Qualifications:

  • Life Science degree.
  • Regulatory CMC specific knowledge and experience.
  • Understanding and application of scientific/technical principles, concepts, theories, and standards.
  • Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotechnology industry.

What We Offer:

A dynamic work environment that values collaboration, innovation, and continuous learning.

Opportunities for growth and development in a rapidly evolving industry.

A team-oriented culture that promotes open communication and mutual respect.

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