(Sr) Regulatory Affairs Consultant Cta/ind
3 days ago
As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Travel: Yes
- Glassdoor Reviews and Company Rating
**Success Profile**:
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
**Rewards**:
- **Global Impact**: We are one truly global team working together to propel each client´s journey ahead faster.
- **Balance**: We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Freedom**: The ability to innovate, ask “what if” and try new solutions without fear of failure.
- **Variety**: Opportunities to work on multiple accounts - never boring
- **Management**: Strong management with depth of experience working for global health authorities.
We are looking for**Regulatory Affairs Professionals**CTA/IND**on various levels (Consultant, Senior Consultant, Principal Consultant) for a client dedicated project within Parexel FSP Group.
The role can be home or office based in various European locations.
As the Regulatory Affairs CTA/IND Specialist you will provide technical/coordination support and expertise within the client's **vaccines group** in particular for the R&D, Global Quality Vaccines & Legal/Patent departments and outside of the group (eg: EMA) to ensure:
- The appropriate project management related to CTA/IND process with the different stakeholders by issuing the master planning/strategy to ensure timely due submissions and approvals of CTA’s/IND in compliance with ethical and regulatory standards
- The upload and maintenance of the third country form (related to articles 41 & 46) via the EMA gateway
- The appropriate project management related to DSUR process with the different stakeholders (eg: NSC - LOC’s)
You will also ensure the following project management for CTA by:
- Flagging operational issues and proposing solutions in a timely manner
- Supporting the LOCs for their submission to their authority and ethics committees by providing help and guideline on procedural and administrative matters
**Skills and Experience required for the role**:
- A background in clinical trial management
- Good expertise in CTA and associated regulations
- Ability to coordinate projects also with external partners
- Good prioritization skills in function of business impact and criticality (project management)
- Good organizational, interpersonal and communication skills
- Flexibility and proactive thinking to meet business requests
- Rigor, quality mindset
- Team player
- Demonstrated skills for training and presentation
- Fluency in spoken & written English. Knowledge in French or Italian is a plus.
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