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Role: Regulatory Affairs Specialist 

Role summary: Country regulatory specialist working with local health authorities, local distributors and different departments within global and local

Region: Saudi Arabia, Bahrain, Kuwait, Qatar, Oman, United Arab Emirates, Lebanon, Jordan, Egypt and passive support to South Africa.

Location: Dubai, United Arab Emirates

Key accountability:

1. Prepare and manage new product submissions for regulatory approval to the local Health Authority (HA). Both eCTD and paper submissions (on project basis only)
2. Liaise with Global regulatory colleagues to execute the approved regulatory filing strategies for the region.
3. Labeling: Prepare files, liaise with partners, submit to HA, track, archive and manage label update submissions across Middle East
4. Prepare and submit for HA review - CMC amendments to product dossiers.
5. Respond to HA queries on both new product and amendment submissions.
6. Life cycle management of registered drug products
7. Keep track of periodic license renewals and submit to HA so as to maintain uninterrupted supply of drugs to patients.
8. Liaise with local marketing and market access divisions to provide regulatory support.  This includes formal quarterly regulatory feedback sessions.
9. Review and approve all local artwork
10. Participate in site to market meeting with the cross functional teams to plan new product launch.
11. Attend quarterly Gulf compliance committee meetings and keep track of compliance topics.
12. Regulatory review of promotional material and clinical trial study medication labeling.
13. Communicate with HA regarding the Client's initiated product license withdrawals and recalls, as per the directions from Global/SOP.

1. Liaise with local partners to manage day to day regulatory activities in the region
2. Update VERITY (Regulatory information repository), local archives and local labelling SharePoint
3. Support South Africa regulatory activities

Day-to-day activities:

1. Conduct day to day telephonic and written follow up with local distributors or BMS partners on ongoing and outstanding regulatory activities.
2. Attend meeting with the HA on current and outstanding approvals as and when required.
3. Interactions with ISLs; CMC product managers; Local, Global labelling leads on planned and current product submissions.
4. Maintain database entries in GRS tracking systems viz.: VERITY, Share Points, archives

Administrative tasks:

1. Prepare, copy and bind HA submissions as per HA formatting requirements.
2. Prepare e-CTD dossier as per HA requirement
3. Receive and processes all incoming HA correspondence.
4. Perform local regulatory document management – includes electronic/ hard copy filing of all product dossiers, HA submissions, labelling text and general product correspondence.
5. Archive regulatory documentation in line with the company directives.
6. Provide regulatory inputs to support tender applications in the region if applicable.
7. Provide regulatory support to South Africa regulatory partners as and when required

Special Projects:

1. Provide regulatory support to implement serialization, track & trace requirement (if required only)