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.
Medicine & Regulatory Affairs | BI Careers (boehringer-ingelheim.com)
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.
Our Company - Boehringer Ingelheim A Family-Owned Business | Boehringer
Ingelheim (boehringer-ingelheim.com
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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