Remote Affairs lead Jobs – 10 Open Jobs Today

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Regulatory Affairs Specialist

ProductLife Group -
Remote

Apply Now

Job details

Permanent | Contractual / Temporary
8 days ago

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Multilingual
English
Project management
Bachelor's degree
Data entry
Computer skills

Full job description

A Specialist profile will ensure efficient project execution, better quality outcomes, and reduced dependency on supervision. Therefore, hiring a Specialist is essential to meet the role requirements effectively.

MAIN ACTIVITIES FOR THE JOB

Contribute to regulatory activities performed on the RA Platform/the Hub.
Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers.
To contribute to the production of client administrative documents and reports to be included in regulatory submissions.
Support for Initial MA application, all kind of LCM activities.
Act as (Single) Point of Contact and oversee clients’ portfolios.
Cross-functional co-ordination.
Communication with external vendors.
Communication/Co-ordination with client and participate in client’s meeting, preparing MoM etc.
Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements.
Systems Management and Administration
Document and track regulatory submissions and regulatory authority approval.
Gain regulatory authority approval
Provide regulatory support to clients and associate companies.
Assess regulation and inform the clients about the impact on their products or activities.
Liaise with sponsor head-office and affiliate departments on regulatory issues.
Liaise with external regulatory authorities as required.
Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling.
Review tasks for, support and mentor Regulatory Affairs Associates.
Provide on-going regulatory support to the Regulatory Affairs Team. Lead and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
Contribute to data entry in PLG tools enabling measurements of KPI and metrics for regulatory services supplied by the platform/hub.
Control that invoicing is correctly set.

Assist the RA Platform or Hub Leader or Coordinator in presales:

Ensure providing technical support to presales

Ensure adequate technical description of the proposals and support sales for quotation evaluation

Ensure that invoicing is done correctly.
Contribute to the input of data into PLG tools enabling
KPI/metrics for regulatory services provided by the platform/Hub.

Required education:

Bachelor’s or higher degree in a science related field, or equivalent experience.

Required experience :

7-8 years of EU RA technical and project management experience

Required languages:

Good English language and grammar skills (written fluency a must, verbal fluency preferred)
Any other language on top of good English would be a plus

Required technical skills:

Good computer skills and the ability to learn appropriate software
Good understanding of regulatory tracking database software, MS Word, MS Excel, MS PowerPoint etc.

Additional experience and/or skills:

Excellent organizational and interpersonal skills
Ability to work well within a team

Apply Now

Refine Your Search

affairs lead jobs in remote

Regulatory Affairs Specialist

Government Affairs and Public Policy

Associate Director - Scientific Communications

Consultant - Veeva RIM Professional Services

Quality & Regulatory Lead (Independent Contractor)

Compliance SME – Medical Device Software

Business Development Manager (Global Payments)

Manager - Software Engineering

Enterprsie Sales Manager Pune

More jobs to discover

I want to receive the latest job alerts for affairs lead in remote

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MAIN ACTIVITIES FOR THE JOB

Required education:

Required experience :

Required languages:

Required technical skills:

Additional experience and/or skills:

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