Regulatory Affairs Executive
3 days ago
Regulatory Affairs Executive-223518
**Regulatory Affairs Executive - **223518
**OUR COMPANY**
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.
Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.
**THE POSITION**
To execute the Regulatory Affairs local activities according to regional Regulatory Affairs strategies and local business priorities within the defined time lines.
Maintain product registrations and Regulatory Affairs databases; ensuring business continuity in compliance with internal and external regulations and requirements.
Provide regular regulatory intelligence on changes in regulatory environment, competitor activity to enable the business to realize any risks or opportunities arising in the RA environment.
Collaborate cross-functionally and make sure that all relevant stakeholders are timely and pro-actively updated on relevant RA topics.
Have a strong interaction and partnership with the assigned authorities across in the operating unit; maintain efficient relationships with related Regulatory service Providers (local agents and vendors). Carry out agreed actions for the assigned local projects.
**Tasks & responsibilities**:
**Product Responsibility**
- Product registration.
- Acts as a product 'passport' enabling function by obtaining local marketing authorizations and appropriate legal approvals.
- Maintains licenses for products and seeks approval for product re-registration on permit / license expiry in accordance with the local legislations.
**Product Information**
- Provides packaging component updates. Evaluates the preparation of the product artworks for data accuracy as per the latest product information.
- Maintains product information accuracy and appropriateness with respect to drug contents, drug safety / and pharmacovigilance and drug usage information.
- Maintains effective communication with Marketing and Medical Affairs Departments to ensure that the product information integrity and communicates changes in product content where necessary.
**Regulatory compliance**
- Maintains regulatory compliance of products with internal and external bodies at the international, regional and local levels. Adapts local requirements and procedures to corporate standards
- Reviews product / legislative updates received from BI Corporate or local health authorities and ensure that products are compliant.
- Maintains an in-house repository of relevant laws and local authority guidelines. Archives regulatory updates issued by health authorities across the OPU region. Communicates updates and assists with special requests from Corporate regarding local / regional regulations.
- Ensures company compliance to regulatory obligations and maintains licenses/authorizations for existing products
- Communicates periodically to the agencies on PSUR and safety data issued by BI Corporate and forwards to the QPPV in the OPU.
**Country responsibility**
- Support the local Regulatory Affairs team with their products of responsibility to feed in the country requirements for their plan, to respond to these needs within the set timelines identified by the team member.
- Prepare and communicate a regulatory intelligence report on any new issued regulation / guideline / circular and to brief the regulatory colleagues.
- Support the local Regulatory Affairs team with the local submission and follow up with the local Health Authority for the country of concern.
**Requirements**:
- Professional post graduate degree is a plus
- High English proficiency is a must.
At least 3-5 years relevant experience in regulatory national and/or regional scope of work in Egypt interacting with EDA.
- Good understanding of the regulations and related guidelines in Northeast Africa is preferable.
- Good understanding of Regulations (Pharmaceutical and Biological is a must).
- Good knowledge of different regulatory dossiers : CTD, e-CTD, NeeS,..is a must.
**WHY BOEHRINGER INGELHEIM?**
With us, you can grow, collaborate, innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.
We also offer a competitive salary, generous amount of vacation time, numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym, best-in-class cafeterias and coffee bars to keep you energized and healthy and other various benefits and rewards. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse a
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