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Regulatory Affairs

Job description

  • Job Title & Department: Regulatory Affairs – RA
  • Location: Shamirpet, Hyderabad
  • Reports To: Regulatory Affairs Manager / Managing Director

Job Summary:

  • We are seeking a skilled & motivated Regulatory Affairs to join our SPAL team.
  • The successful candidate will play an important role in supporting submission.
  • You will work closely with cross-functional teams to support the development of SPAL in Global.

Key Responsibilities:

  • Preparation and Review of Regulatory documentation in support of oncology drug products for submission to the health authorities, like the FDA, EU, EMA, and other respective agencies.
  • Regulatory strategy development for oncology products should consider both market requirements and various routes of regulatory approval.
  • Compliance & Reporting: Conduct all regulatory activities about oncology to assure compliance with all applicable regulations and standards.
  • Labelling & Advertising: Review and approve all labeling for oncology products, promotional material, and patient material within the confines of regulatory guidance.
  • Cross-functional Collaboration: Engage with clinical, quality assurance, medical affairs, and other internal teams in support of oncology products.
  • Regulatory Intelligence: Follow company thoughts on regulatory trends and changes in oncology regulations to communicate those updates to the team.
  • Regulatory Meetings: Support in preparing documents for meetings with regulatory authorities and participate in the discussions to ensure that objectives and outcomes are clearly defined.

Skills & Qualifications Experience:

4-6 years of experience in Regulatory Affairs, preferably in the Oncology pharmaceutical or General Medicine pharmaceutical industries, with a good focus on Industry standards. Skills:

  • Strong communication skills, both written and verbal, with the ability to prepare clear regulatory documents.
  • Detail-oriented with the ability to handle multiple projects in a fast-paced environment.
  • Proficient in regulatory submission tools, databases, and document management systems.
  • Strong problem-solving skills with the ability to adapt to changing regulatory environments.

Working Conditions:

  • Full-time position & Six (6) days’ work a week.

To Apply: Please submit your resume and cover letter to our email – jobs@spaccurelabs.com

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