Are you our new colleague?
ERA Consulting Ltd., a Pharmalex company, are currently seeking a scientifically curious regulatory professional that is looking to take the next step in their career.
As a Regulatory Affairs Clinical Trials Manager in the ERA team you will be involved in multiple Regulatory programs for biotechnology and pharmaceutical companies, and strategise and execute on various Regulatory Agency submissions operationally.
Not only you will support first time filings of new EU MAA but you will also support CTA applications and their ongoing review in Europe, North America, Asia and Australia.
Regulatory Affairs Clinical Trials Manager
- Providing clients with regulatory consultancy services for biologics including project management of development, programs through to marketing authorisation
- Drafting, preparation, and review of documentation for regulatory submissions such as: (CTA IMPD/IND/MAA/BLA/PIP/ODD/EU PRIME Applications, Scientific Advice briefing documents,
- Participation in due diligence activities as part of business development and investment activities by ERA clients,
- Contribution to regulatory strategies for client activities,
- Supporting clients as a subject matter expert,
- Management and delivery of client projects using internal resources, participating in client and agency meetings. Ensuring assigned client projects meet timeline commitments,
- Client relationship management, including oversight of project plans and timelines, budgets, and deliverables,
- Company representation at external conferences, including the provision of training workshops,
- Business development activities (e.g. identifying opportunities for work, new client meetings etc.),
- Supporting and advising the wider ERA family with group projects as required.
- University degree in pharmacy or other natural sciences
- +4 years of experience in a regulatory role in the biotech / biopharmaceutical industry or regulatory consultancy industry.
- Excellent team player
- Ability to implement tactical goals of customer or internal projects within daily work
- A keen eye for detail.
- Excellent skills in written and spoken English are critical to succeed in this role.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.