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Senior Associate Regulatory Affairs

Employer
i-Pharm Consulting
Location
Dún Laoghaire, Republic of Ireland, Dublin
Salary
Negotiable
Start date
9 Sep 2021
Closing date
23 Sep 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Senior Associate Regulatory Affairs

12 month contract

Dun Laoghaire site preference - however can be remote

€34.60 per hour

37.5 hours per week

Description:

Group Purpose
Support the coordination, development and/ or execution of CMC regulatory registration activities in accordance with commercialization strategies and global regulatory plans.

Job Summary

This individual is responsible for the registration document(s) procurement, preparation and coordination.

This individual will serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation.
Works in collaboration with the Site RA CMC Team and other Global/Regional Teams as needed.

Key Activities


- Registration document(s) procurement, preparation, coordination submission and archival
- Coordinates legalization and delivery of registration documents following the instructions provided in the request.
- Maintains tracking and organization of documentation, including uploading in CSD tool or other document repository.
- Supports the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed.
- Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.

Knowledge and Skills


- Excellent written and verbal skills
- Knowledge of Good Manufacturing Practices (GMP) and good documentation practices
- Strong written and oral communication skills
- The applicant should have basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS)
- Proficient use of MS Office tools, SharePoint and strong computer aptitude.
- Must have ability to work within team environment, but maintain a level of autonomy for managing daily tasks and activities
- Solid working knowledge on document management systems such as Documentum.

Education & Experience
Bachelor/Master's degree (Regulatory, Life Sciences, Biotechnology or related discipline)
Candidates MUST have GMP site experience , with some sort of reg experience
Candidate needs to Regulatory filings at least

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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