Regulatory Affairs
2 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**on various levels (Senior and Principal Consultant) for a client dedicated project within Parexel FSP Group who are **CMC **Tech**nical Regulatory Writers. Technical Regulatory Writer is involved in the client’s regulatory activities related to new & existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions.
**Responsibilities**:
- Write CMC, “facility and equipment” parts and new files for WW regulatory File
- Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion
- Ensure the coordination with the departments involved in the writing/review process
- Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities
- Monitor that supportive data provided by other departments are compliant
- Report significant issues
- Manage the projects within all tracking tools
- Assess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities.
**Skills and Experience required for the role**:
- Experience in writing CMC (technical) parts of regulatory documents (registration files or variations).
- Experience working in validation/QA/production in Biologics/Pharmaceuticals industry
- Knowledge of regulatory procedures / systems / guidances
- Knowledge of biologic process and process equipment.
- Knowledge of Qualification / Validation principles.
- Manages own time to meet agreed short-term targets
- Analytical skills, creative and critical mind; ensures the coherence between contributions / quality of final results
- Good level of spoken and written English (other European language would be a plus)
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