Regulatory Affairs Manager

3 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

Job Title: Regulatory Affairs Manager

About the Role

We are seeking a highly skilled Regulatory Affairs Manager to oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia.

Key Responsibilities:
  • Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines.
  • Coordinate with internal teams to ensure timely and accurate submissions.
  • Manage regulatory responses to queries and deficiency letters from health authorities and clients.
  • Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation.
  • Lead lifecycle management activities for approved products.
Required Skills and Qualifications:
  • Proven experience in regulatory affairs within the pharmaceutical industry.
  • Strong knowledge of regional regulations, including ASEAN, South Asia, East Asia, and Middle East.
  • Excellent communication and project management skills.
  • Bachelor's degree in a related field.
Benefits:

This role offers a competitive salary and benefits package, as well as opportunities for professional growth and development.

Other Information:

This is a full-time position, based in [Location]. We offer a dynamic and supportive work environment, with a team of experienced professionals.

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