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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 – hr@spaccurelabs.com