Regulatory Affairs Officer

1 week ago

India ProductLife Group Full time

**Specific activities and responsibilities**:
Australia / South Africa / Brazil and GCC experience

**Required education**:
Degree in relevant life science discipline

**Required experience**:
2-4 years relevant experience for Australia / South Africa / Brazil and GCC experience

**Required 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.
- 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
- 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
- Coordination and administrative support of variation, Renewal Procedure, RtQs and PSUR inc. requesting/securing centrally provided documentation and EDMS support eg Veeva Vault RIM Experience of PV would be beneficial
- Coordination and management for CPP requests (as required).
- Coordination and administrative support relating to cessation of marketing / sunset clause / withdrawal of MAs.
- Coordination and administrative support for Annual Safety Updates/HA instructed safety updates
- Updating Veeva Vault submission data as required

  • Regulatory Affairs Specialist

    2 days ago

    india Frisch Medical Devices PVT LTD Full time

    Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej CrossroadsDepartment: RAReports To: RA Head and Regulatory Department at HO /DirectorEmployment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half DayPreferred Gender : M/FExperience: Minimum 2 yearsJob Summary:We are seeking a proactive and...

  • Regulatory Affairs Specialist

    2 weeks ago

    India Frisch Medical Devices PVT LTD Full time

    Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej CrossroadsDepartment: RAReports To: RA Head and Regulatory Department at HO /DirectorEmployment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half DayPreferred Gender : M/FExperience: Minimum 2 yearsJob Summary:We are seeking a proactive and...

  • Regulatory Affairs

    2 weeks ago

    India Sunrise Remedies Full time

    Sunrise Remedies Job Opening for Regulatory Affairs (RA). **Experience**: Minimum 2 Years **Industries**: Pharmaceutical Company **Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm **Job Location**: Santej Ahmedabad. **Key Responsibilities**: - Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices,...

  • Regulatory Affairs Executive

    1 week ago

    India Kumar Organic Products Full time

    **Entry Level**: **Education**: Chemistry background - BSc - Chemistry / MSc - Chemistry **Notice Period**: Immediate - 30 days **Job type**: Full Time **Industry**: Specialty chemicals, Beauty & Personal Care, Pharmaceutical **Job location**: - India (Head Office)_ **Salary**: Best In Class **Benefits** Group Medical Insurance Group Accidental...

  • Regulatory Affairs Specialist

    2 days ago

    Mumbai, India Tek Support Full time

    Job Description Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health...

  • Expert Regulatory Affairs

    1 week ago

    India dsm-firmenich Full time

    Job Title **:Expert Regulatory Affairs ( Contract for 18 months)** Job Type : Remote / WFH / Hybrid Location : India At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to...

  • Regulatory Affairs Manager

    2 weeks ago

    India eteraflex connects Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    We are seeking an experienced Clinical Trial Regulatory and Operations Manager based in Delhi/NCR who will ensure the timely initiation and successful execution of clinical trials. The ideal candidate will have extensive knowledge of India's clinical trial regulatory landscape, CDSCO submissions, import licensing, and operational oversight of clinical...

  • Regulatory Affairs Executive

    6 days ago

    India Biotech Healthcare Full time

    Role Objective Key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. The role involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance...

  • Regulatory Affairs Manager, South Asia

    5 days ago

    India Align Technology Full time US$ 1,04,000 - US$ 1,30,878 per year

    DescriptionJoin a team that is changing millions of lives.Transforming smiles. Transforming lives. Transforming an industry.At Align Technology, we believe a great smile can transform a person's life, so we create technology that gives people the confidence to take on whatever's next. We revolutionized the orthodontic industry with the introduction of the...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    India vueverse. Full time

    Key Responsibilities:- Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.- Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.- Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.-...