Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
We are looking for the Regulatory Affairs Specialist who will be working with Ministry of Health, local distributors and different departments within global and local BMS.
The person will be responsible for the BMS Celgene portfolio in the Gulf, Eastern Mediterranean Cluster and Maghreb Region.
Key accountabilities:
- Prepare and manage new product submissions for regulatory approval to the local Health Authority (HA).
- Liaise with Global regulatory colleagues to develop regulatory filing strategies for the region.
- Prepare and submit for HA review, CMC and Labelling amendments to product dossiers.
- Respond to HA queries on both new product and amendment submissions.
- Life cycle management of registered drug products
- Keep track of periodic license renewals and submit to HA so as not to disrupt imports.
- Liaise with local marketing and market access divisions to provide regulatory support. This includes formal quarterly regulatory feedback sessions.
- Review and approve all local artwork
- Participate in site to market meeting with the cross functional teams to plan new product launch.
- Attend quarterly Gulf compliance committee meetings and keep track of compliance topics.
- Regulatory review of promotional material and clinical trial study medication labeling.
- Communicate with HA regarding BMS initiated product recalls, as per the directions from BMS Global.
- Liaise with local partners to manage all regulatory activities in the region
Day-to-day activities:
- Conduct day to day telephonic and written follow up with local distributors on ongoing and outstanding regulatory activities.
- Prepare dossiers for HA submissions – paper and eCTD.
- Attend meeting with the HA on current and outstanding approvals as and when required.
- Daily interactions with ISLs; CMC product managers; Global labelling leads on planned and current product submissions.
- Coordinate with local medical advisor to review local labels for accuracy and compliance.
- Maintain e-time and other BMS repositories.
- Archiving
Requirements:
- University Degree in science stream
- 5+ years of relevant pharmaceutical regulatory experience within the large multinational organization
- Experience working in the Middle East and Maghreb Region (preferred)
- Experience working cross-functionally
- Ability to work independently with a minimal supervision
- Good communication and interpersonal skills
- Written and spoken fluency in English (Arabic and French is added advantage)
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
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