 UMEDICA is looking to hire a Head of Regulatory Affairs at its Vapi (Gujarat) manufacturing facility, which is accredited by global regulatory agencies such as the EU, PICs, Local FDA, and has been inspected by the USFDA. This role requires a dynamic and experienced professional to handle regulatory strategy, filings, and lifecycle management for various markets, including the US, Europe, and the UK.
Key Responsibilities:
- Oversee regulatory affairs strategies and department management.
- Provide regulatory support to FR&D and QA/QC teams.
- Ensure compliance with EU, US, UK, and PIC/s regulatory requirements.
- File original ANDAs for the US, ANDS for Canada, EU MAs, and UK PL applications.
- Support business development teams for product registration in multiple regions.
- Manage a team of regulatory professionals and provide coaching.
- Participate in management reviews and ensure good regulatory practices.
- Budget management for the regulatory affairs department.
- Stay updated on regulatory trends and implement compliance strategies.
Qualifications:
- Education: Master’s in Pharmacy or Science. A postgraduate degree in QA/RA is preferred.
- Experience: Minimum 20+ years in the pharmaceutical industry with 15+ years in regulatory filings and team management.
- Skills: Strong leadership, communication skills, and experience in global regulatory compliance.
Interested candidates can share their resumes at avinash.s@umedicalabs.com.
Last date to apply: 30th September 2024.
