fulltime vacatures bij Zwiers Regulatory Consultancy

Are you interested in working in the ever-changing regulatory environment?

You will:

• Perform gap analysis & due diligences for customer's projects
• Analyse, interpret and translate gaps to create a strategy and actions for CMC data generation
• Define (global) Regulatory Affairs CMC strategies for customers, including health authority interaction opportunities
• Provide technical writing for clinical trial applications (eg IND eCTD modules 2.3 and 3, QIMPD-EU) for phase I to pivotal clinical trials, marketing authorization applications (BLA/MAA) and post approval variations
• Write CMC related regulatory documentation (eg ODD/PIP/Briefing Book/labeling/PRIME and RMAT applications)
• Support customers with submissions and health authority requests for information

You have:

• An MSc/PhD in Pharmacy, Chemistry, Life Sciences
• At least 5 years relevant experience in Regulatory Affairs CMC
• ATMP and/or Biologics experience
• Strong technical writing and editing skills
• The ability to handle stringent deadlines
• Strong communication skills

Offer

Salary will depend on education, knowledge and experience

Contact

For further information you can contact us at or call us at +31 (0) 6 344 848 51

We look forward to your application. You can apply by sending us your CV and motivation .

Local safety officer

You:

• have a BSc degree or higher (preferably in life or health sciences, pharmacy, nursing, medicine, or biology)
• have 2 or more years of experience in Pharmacovigilance (PV) / drug safety
• are eager to take on a job in which you will be local safety representative (and back-up LQPPV) for products in the Benelux
• are looking forward to take on any relevant additional task (e.g. case management, HA interactions, audits, reconciliation, surveillance)

We:

• stimulate you to give us a call before applying
• offer a working environment in which a professional approach goes hand-in hand with a personal touch
• invite you to apply by sending us your CV and motivation .

Experienced Regulatory Consultant Medical Devices

You:

• have an MSc/PhD in Life Sciences, Medical Biology, Chemistry, Pharmacy
• have substantial experience in Development & Regulatory Affairs in the Medical Device industry
• like to be in a dynamic strategic position in medical device development and life cycle
• will write and update technical documentation (eg. BE, CE, RM)
• will interact with notified bodies and authorities
• will write regulatory strategy plans
• perform gap analysis

We:

• will coach you and provide training, if needed
• invite you to apply by sending us your CV and motivation .

Business Development Manager Benelux

You:

• look forward to being responsible for business development for our company (NL, Benelux) authorities
• have experience with setting up and executing business development plans, portfolios, deal pipelines, prospect meetings, bid defences in line with company strategy and sales targets
• have a MSc in business development and a minimum of 5 years of experience in it in the life science industry
• are a good communicator (in writing and verbally in Dutch and English) and team player
• are able to take on challenging tasks in a creative, proactive and convincing way while handling stringent timelines

We:

• offer an international working environment in which a professional approach goes hand-in hand with a personal touch
• invite you to apply by sending us your CV and motivation .

Local Regulatory Affairs Manager

You:

• look forward to being responsible for timely submission and correspondence of regulatory content to national (NL, Benelux) authorities
• have experience with local/regional regulations, preparation of local submission documents, translations of product information, eCTDs and variations and promotional materials
• have a BSc/MSc in Life Sciences and a minimum of 2 years of relevant regulatory experience
• are a good communicator (in writing and verbally) and team player
• are able to handle stringent deadlines and manage multiple projects simultaneously

We:

• will coach you and provide training, if needed
• offer a working environment in which a professional approach goes hand-in hand with a personal touch
• invite you to apply by sending us your CV and motivation .

Experienced Regulatory Strategy Consultant

You:

• have an MSc/PhD in Pharmacy, Medical Biology, Chemistry, Life Sciences
• like to be in a dynamic strategic position in drug development and life cycle
• have three to five years of experience in Regulatory
• will be involved in innovative drug development
• will prepare regulatory dossiers for clinical trial applications, orphan drug designations, paediatric investigational plans, marketing authorisation procedures and health authority meetings
• be involved in defining global regulatory strategy
• want to live up to the Zwiers "professional approach with a personal touch" spirit

We:

• will coach you and provide training, if needed
• invite you to apply by sending us your CV and motivation .

Medical Writer

You have:

• an MSc/PhD in Pharmacy, Biomedical Sciences, Life Sciences
• scientific and technical writing and editing skills (English)
• an eye for detail
• the ability to handle stringent deadlines
• the eagerness to learn, develop and excel
• the ability to communicate in a convincing way
• at least 3 years of experience as a medical writer or comparable writing position