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Regulatory Affairs Executive

4 weeks ago

Riyadh, Saudi Arabia Boehringer Ingelheim Full time

**Regulatory Affairs Executive**
**-**
**233533**

**THE POSITION**

Do you have MAH (Marketing Authorization Holder) registration experience? Do you have product life maintenance (variation, leaflet update, renewals) experience in regulatory affairs? Are you familiar with SFDA portals/systems?

We are looking for an accountable & agile
**Regulatory Affairs Executive (RA Executive) **, located in Riyadh, Kingdom of Arabia. This position directly reports to Regulatory Affairs Manager.

**Tasks & responsibilities**:

- Execute the RA local activities according to Regional RA strategies and local business priorities within the defined timelines.
- Maintain product registrations and RA 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.

**Job Requirements**:

- At least 1-2 years of pharma experience with regulatory focus, preferably in multi-national company.
- Experience of direct interactions with Regulatory Authorities is an asset in KSA / and preferably GCC countries.
- Bachelor in Pharmaceutical Science or similar science.
- Arabic/English fluency and computer literacy.
- Saudi national.
- Good understanding of regulatory compliance and knowledge of local regulatory requirements for product registration.
- Good interpersonal skill with excellent communication.

**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.

**WHY THIS IS A GREAT PLACE TO WORK**

Boehringer Ingelheim received the Top Employer award in the Kingdom of Saudi Arabia. The Top Employers Institute highlighted the organization’s outstanding efforts in employee engagement, talent development and well-being, when compared with the industry benchmark.

**Job**
- Medicine / Regulatory Affairs

**Primary Location**
- Africa, Asia, Australasia-SA-Ar Riyad

**Organization**
- SA-Boehringer Ingelheim Saudi Arabia

**Schedule**
- Full-time

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