Manager, Regulatory Affairs Emea
vor 5 Monaten
**Why Join Us?**
- Be a hero for our rare disease patients_
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team
_. _
**Position Summary**:
**_ ultra_**_focused - Work together to fearlessly uncover new possibilities_
The Manager, Regulatory Affairs, Europe, Middle East and Africa (EMEA) will work closely with the EMEA Regulatory team, global regulatory colleagues, functional areas, and project teams to support regulatory activities related to Ultragenyx products in development and marketed products in the EMEA region. The individual must possess general knowledge of EU (MENA preferred) rules, regulations, and guidance's governing the commercialization and development of drugs and biologics in all phases.
**Work Model**:
Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.
**Responsibilities**:
- Provides input and guidance on EMEA regulatory requirements throughout product clinical development and life cycle management to the product team.
- Creates and maintains submission schedules and timelines with regulatory operations and the cross functional team, ensuring timely delivery of high quality documents.
- Prepares and manages regulatory submissions for investigational and approved products (e.g. CTAs, MAAs, variations).
- Reviews regulatory documents to ensure appropriate content.
- Manages preparation of responses to regulatory agencies.
- Assists in regulatory strategy development.
- Supports planning and conduct of Agency meetings including coordination of briefing documents.
- Keeps current with EMEA region guidelines and regulations.
**Requirements**:
- BA/BS in a life sciences study and 4-6 years of relevant experience working in the pharmaceutical/ biotech industry. An advanced degree is preferred.
- Working knowledge of EU (MENA preferred) regulatory affairs requirements for drug development
- Experience in communicating regulatory strategy, submission documents and plans both internally and externally
- The desire and ability to work in a fast-paced environment
- Strong collaboration, team work, organizational skills and attention to detail
- Travel: 5 % **#LI-CK1** **#LI-Hybrid**
**_Full Time employees across the globe enjoy a range of benefits, including, but not limited to:_**
- **_Generous vacation time and public holidays observed by the company_**
- **_Volunteer days_**
- **_Long term incentive and Employee stock purchase plans or equivalent offerings_**
- **_Employee wellbeing benefits_**
- **_Fitness reimbursement_**
- **_Tuition sponsoring_**
- **_Professional development plans_**
- _Benefits vary by region and country_
- See our _
- CCPA Employee and Applicant Privacy Notice_
- ._
- See our _Privacy Policy
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