Regulatory Compliance Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeCompliance Full time
Regulatory Compliance Specialist

We are seeking a highly skilled Regulatory Compliance Specialist to join our team. In this role, you will be responsible for maintaining close cooperation with regulatory authorities to discuss requirements, strategies, and knowledge of global product dossiers to stay up-to-date.

  • Maintain close cooperation with regulatory authorities to discuss regulatory requirements, strategies, and knowledge of global product dossiers.
  • Conduct training to ensure appropriate knowledge and regulatory compliance.
  • Support the area in effective change control, examining reg. relevance and pre-evaluating amendments to products.
  • Act as a contact person for regulatory matters and intermediary between regulatory authorities and production unit at strategy decisions and in the product life cycle.
  • Support timely reviews of documents for defined products; support with and identification of challenges in the course of regulatory compliance audits.
  • Implement and overview initiatives to improve (regulatory) compliance.
  • Coordinate, guide, and support preparation of responses to health authorities for specific products.
Required Skills and Qualifications
  • Advanced university or academic degree in chemistry, biology, pharmacy, engineering, or equivalent.
  • Fluent English language skills.
  • More than 3 years of experience in an operational GxP area, in manufacturing, development, or QA or regulatory affairs; with thorough knowledge of biologic drug substance manufacturing processes for recombinant proteins and/or nucleic acids.
  • Ability to communicate effectively and take quality decisions during challenging situations.
Benefits

This is an exciting opportunity to work in a dynamic environment and contribute to the success of our organization.

Others
  • Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership, and project management experience.
  • Ability to work independently and effectively in international, complex, and multifaceted environments.

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