Senior Manager, Regulatory Affairs
- Contract Type
Role: Senior Manager, Regulatory Affairs
Location: any of our European office locations
Contract Type: Permanent
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
We’re looking for a talented and energetic Senior Manager, Regulatory Affairs to join our team. This job will be recruited within Europe. The role can be home or office based and full/part time/flexible working patterns can be considered.
You'll be accountable for:
- Developing effective regulatory strategies, procedures and systems to facilitate efficient review and approval of regulatory submissions.
- Management and oversight of European regulatory submission activities with the exception of clinical trial applications
- Primary regulatory agency contact for assigned project
- Preparation and project management of paediatric investigation plans, orphan drug applications, scientific advice briefing packages etc
- Coordinating the preparation of regulatory submissions, and reviewing all documents submitted to regulatory agencies
- Providing consulting services by writing and reviewing global regulatory strategy documents for medicinal products and devices
- Communicating with regulatory agencies on behalf of clients
- Potentially participating in business development activities
You'll need this to be considered:
- Undergraduate degree or its international equivalent in clinical, science or health related field from an accredited institution or a licensed healthcare professional.
- Extensive experience working in Regulatory within Clinical Research
- Strong experience in European regulatory submission activities
- Thorough knowledge of ICH and local regulatory authority drug research and development regulations preferred.
- Experience working with internal and external customers/vendors to meet project specific goals.
Expertise and know-how
- Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of web based communication tools for conferences
Personal skills & behaviours
- Fluent verbal and written English.
- Excellent team player, collaborative and able to build an effective team.
- Ability to multitask and work effectively in a fast-paced environment with changing priorities.
- Strong verbal and written communication and mediation skills.
- Excellent organizational and time-management skills, able prioritize work to meet deadlines.
- Accountable, dependable and strong commitment.
- Is customer service focused in approach to work both internally and externally.
- Maintains a positive, results orientated work environment.
KEY WORDS: Regulatory Affairs, Regulatory, Paediatric Investigation Plans, Orphan Drug Applications, Pharmaceuticals, CRO, Contract Research Organization, Permanent, Europe, Ireland, Germany, Italy, France, Spain, Bulgaria, Slovakia, Biotechnology, Office Based, Home Based
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