112 - 117 Regulatory Affairs Officer

2 days ago

Remote, India ProductLife Group Full time

**Responsibilities**:

- Preparation and submission of EU Marketing Authorisation Applications (Module 1,2,3) for Initial MAA and LCM (via DCP, MRP and NP)
- Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
- Ensuring compliance with all regulatory processes including MHRA and HPRA
- Management of artwork generation
- Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva (or comparable EDMS), DocuBridge
- Building the submission backbone and handover to RegOps for Publishing;
- Submit Published packed via CESP/national portal.
- Follow-up with the authorities and close out changes (inform affiliates etc.), track approvals, update RA tools

Profile
- Experience of promotional/non-promotional activities would be an advantage
- Experience of CMC-RA and/or Reg-Ops would be an advantage
- Good IT skills/knowledge
- Good organisational skills
- Good communication skills
- Pro-active attitude and able to work on own initiative as well as part of a team
- Ability to prioritise different workloads/multi-task
- Personal responsibility for ensuring a high standard of work

Technical Skills
- Lifecycle maintenance experience
- Providing support during external and unannounced audits.
- Responding to internal requests for technical and/or regulatory information.
- Preparation and submission of Technical/Site Transfer Applications
- Assisting with the preparation of Marketing Authorisation Applications
- Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
- Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
- Ensuring compliance with the regulations of the assigned Countries within EU Region
- Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva (or comparable EDMS), LorenZ, Trackwise etc
- A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
- General regulatory administration duties and compliance requirements
- Management of artwork generation

**Job Types**: Full-time, Permanent

**Benefits**:

- Health insurance
- Paid sick time
- Paid time off
- Work from home

Schedule:

- Day shift

Work Location: Remote

**Speak with the employer**

+91 9824104782

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