We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, PharmaLex is your career opportunity. PharmaLex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance..
Manager, Regulatory Affairs
Executes defined operational and strategic tasks in the Regulatory Affairs department in the sector of human medicinal products with special emphasis on the relevant European/US/International regulatory requirements.
- Participation in all regulatory development processes to obtain first European and non-European Marketing Authorizations for human medicinal products (initial MAA)
- Execution of client timelines by coordinating project teams comprised of internal and external BPE staff
- Creation, revision, editing, archival and maintenance of regulatory documentation
- General guidance (consultancy) on technical requirement for Regulatory Submissions (PIP/ODD/PRIME/Scientific advice/CTA applications/ Annual Reports/DSUR etc)
- Preparation of diverse documents for Scientific Advice Meetings with regulatory authorities (BB, Slides, Official minutes)
- In close collaboration with business development, drafting of SOW for new projects for client approval
- Communication with the Health Authorities (email, telephone, submission portal data entry) on behalf of the client
- Active on the job learning and distribution of department relevant expertise (regulatory precedence /intelligence)
- Literature searches/regulatory intelligence from EPAR/drugs@FDA to assist in provision of regulatory strategy
- Support in the preparation, quotation, and invoicing for Regulatory Affairs Projects in close cooperation with the respective scientific lead
- University degree (Masters or PhD) in natural sciences or pharmacy
- Past work experience (trainee) in a pharmaceutical/biotech company
- Complex problem-solving skills
- Ability to see a task to completion
- Structured, analytical, systematic, and ability to conduct independent tasks on instruction
- Excellent team player
- Very good written and spoken communication skills with internal and external customers, colleagues and supervisors
- Ability to discuss and align mid-term goals of collaboration on level of client’s department heads
- Experienced user of the MS-Office package, Adobe Acrobat and database systems
- English skills – fluency in written and spoken language
- 25 days holiday plus bank holidays
- 8% employer pension contribution
- The role can be based at any of our UK locations.
- An opportunity to work within an organisation with a positive work/life balance environment
- Continuous development opportunities through knowledge and experience as well as training
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 receiving your CV and a covering letter, explaining how you meet or exceed the specifications for this position, including your salary expectations on-line.
To apply, please don't hesitate to contact us:
Manager, Human Resources UK/Ireland
Agencies only by prior agreement for the specific job opportunity.