Executive To Manager -Regulatory Affairs (EU Market) - (Injectable / Solids dosage forms)
- Compilation and filing of Dossiers for EU member states through National, MR and DC procedures as per CTD format.
- Handling variations, Renewals and MA transfers according to the country-specific requirements of EU member states.
- Efficiently addressing & compilation of the queries raised by the Regulatory Authority for products submitted for registration as per pre-determined timelines.
- Review and submission of SPCs, Labelling and Package leaflets as per QRD for a different type of EU procedures (MRP, DCP, and National).
- Review and submission of national phase documents for all CMSs within 5 days after EU procedure EOP.
- Review and submission of Mock-ups in various EU languages for National/MRP/DCP submissions as per Blue box and/or country requirements.
- Updating regulatory databases as per the performed activity.
- Submission level and report level publishing of eCTD, NeeS format dossier
- CESP, XEVMPD
- Submission of PSURs & Article 31 referral responses through E-submission gateway.
- EU regulatory Affairs
- MAA application
- Post approval submissions like variations, renewals, PSUR submissions
- Life cycle management
- In-licensing & Out-licensing of products
- Mergers & Acquisitions
- eCTD &NeeS
- Database management
- Submissions through CESP & EMA gateway
- Submissions through National Portals of EU HAs like INFARMED, Portugal & MHRA, UK
Role:Regulatory Affairs Compliance
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Functional AreaLegal & Regulatory
Role CategoryCorporate Affairs
Employment Type:Full Time, Permanent
UG:B.Pharma in Any Specialization
PG:M.Pharma in Any Specialization
People Alliance Workforce Private Limited
People Alliance Workforce Private Limited An ISO 9001:2008, QMS Certified ,TQM based And Indias largest multi interest consulting and business services corporation engaging a variety of organizations, institutions and enterprises in diverse industry . People Alliance is the Indias leader in innovative workforce solutions, creates and delivers highimpact solutions that enable our clients to achieve their business goals and enhance their competitiveness. With over 15 years of experience. These solutions cover an entire range of talent-driven needs from recruitment and assessment, training and development, and RPO&HRPO, to outsourcing and
People Alliance Group began doing business in 2006, offering executive search and recruitment process outsourcing services to our clients. Several years later, we had a vision to establish a single organization that was able to vertically integrate all hiring solutions, a company capable of fulfilling all recruitment and retention needs as well as providing the resources to manage and enhance an organization’s most valuable asset – its people.
Contact Company:People Alliance Workforce Private Limited