Regulatory Affairs Specialist - Dr. Max Own Label
Nabízím práci
Dr.Max
Na Florenci 2116/15, Praha
Nabízím práci
Dnes
O pozici
Pracovní nabídka
What will be your responsibilities?
- Ensure that all medicinal products comply with local and international regulatory requirements
- Submission of post-approval administrative/quality variations and renewals in line with deadlines
- Ensure preparation and update of common RTD
- Change control management (RA MOC action)
- Maintenance of medicinal products lifecycle in docuBridge and preparation of eCTD sequences
- Update and maintenance of RA database in line with submissions/approvals
- Act in compliance with all concerned SOPs
What do we expect from you?
- University degree in Life Sciences (Pharmacy, Chemistry, Life Science or related fields)
- Previous experience on a similar position at least 1 - 2 years
- Knowledge of local and international regulatory requirements and guidelines
- Attention to details, reliability and ability to meet deadlines
- Excellent communication and interpersonal skills, with the ability to build and maintain effective relationships with colleagues and authorities
- Native Czech/Slovak speaker and advanced level of English
What do we offer?
- Working for the largest pharma retail company in CEE with great expansion plans
- A company with a meaningful purpose, an outstanding customer value proposition within an industry offering a resilient, non-cyclical growth pattern
- Global-level job within headquarters with a group-wide impact
- Space for professional growth within a growing organization
- Attractive financial compensation (salary and yearly bonus)
- Flexible working hours, possibility of 1 day/week home office
- 5 weeks of holidays, discount in Dr. Max pharmacies, meal allowance, Multisport card fully covered by employer, public transport contribution, sabbatical leave, pension insurance contribution, referral bonus etc.