- Prepare and manage new product submissions for regulatory approval to the local Health Authority (HA). Both eCTD and paper submissions (on project basis only)
- Liaise with Global regulatory colleagues to execute the approved regulatory filing strategies for the region.
- Labeling: Prepare files, liaise with partners, submit to HA, track, archive and manage label update submissions across Middle East
- Prepare and submit for HA review – CMC 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 to maintain uninterrupted supply of drugs to patients.
- 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 the Client’s initiated product license withdrawals and recalls, as per the directions from Global/SOP.
- Liaise with local partners to manage day to day regulatory activities in the region
- Update VERITY (Regulatory information repository), local archives and local labelling SharePoint
- Support South Africa regulatory activities
- Conduct day to day telephonic and written follow up with local distributors or BMS partners on ongoing and outstanding regulatory activities.
- Attend meeting with the HA on current and outstanding approvals as and when required.
- Interactions with ISLs; CMC product managers; Local, Global labelling leads on planned and current product submissions.
- Maintain database entries in GRS tracking systems viz.: VERITY, Share Points, archives
- Prepare, copy and bind HA submissions as per HA formatting requirements.
- Prepare e-CTD dossier as per HA requirement
- Receive and processes all incoming HA correspondence.
- Perform local regulatory document management – includes electronic/ hard copy filing of all product dossiers, HA submissions, labelling text and general product correspondence.
- Archive regulatory documentation in line with the company directives.
- Provide regulatory inputs to support tender applications in the region if applicable.
- Provide regulatory support to South Africa regulatory partners as and when required
- Provide regulatory support to implement serialization, track & trace requirement (if required only)
Appropriate basic graduation in science. Preferable, degree in Pharmacy with 3-4 years consolidated experience in region
professional experience with 3-4 years of relevant regulatory experience
Key Competency Requirements
Required Knowledge: Up-to-date regulatory knowledge required to do the job as described above
Required Skills: Ability to execute with accuracy, sense of urgency, good communication skills. Must be a team player, agile and willing to take up additional projects as per the company’s requirement.