Regulatory Compliance Specialist

18 hours ago

Hyderabad Secunderabad Telangana, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 28,00,000
Regulatory Compliance Specialist

We are seeking a skilled Regulatory Compliance Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs and a proven track record of ensuring compliance with global product dossiers.

Key Responsibilities:

  • Maintain close cooperation with RA CMC to discuss regulatory requirements, strategies, and knowledge of global product dossiers.
  • Conduct training to ensure appropriate knowledge and regulatory compliance among team members.
  • Support the area in effective change control, examining reg. relevance and pre-evaluating amendments to products.
  • Act as the contact person for regulatory matters and serve as an intermediary between RA CMC and production units at strategy decisions and throughout the product life cycle.
  • Timely review and support the preparation of CMC documents for defined products; identify challenges during regulatory compliance audits.
  • Implement and oversee initiatives to improve (regulatory) compliance.
  • Coordinate, guide, and support in the preparation of CMC responses to health authorities for specific products.

Requirements:

  • Advanced University degree in chemistry, biology, pharmacy, engineering, or equivalent.
  • Fluent English language skills (German desired).
  • 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-driven decisions during challenging situations.

Desirable Requirements:

  • 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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