senior executive - regulatory affairs uk/ie/mt.

Key Responsibilities:

1. Planning and preparation for Renewals / annual maintenance of MA’s assigned; ensure all regulatory requirements of health authorities are met and supply continuity for the products are maintained.
   1. Ensure informing stakeholders (internal & external) and request of document(s), information sufficiently ahead of time, proactively following-up for timely delivery
   2. Detailed review of document to ensure it meets regulatory requirement
   3. Preparation of regulatory submission with a focus on right first time; ensure internal review comments are addressed
   4. Coordination with stakeholders (publishing team, regulatory partner, internal stakeholders or health authorities) to ensure submission before due dates
   5. Following up on approval, prompt responses to any request for information ensuring timely approval and carrying out necessary post approval activities as defined in regulatory procedures
2. Assessing Change request assigned to ensure regulatory assessment along with strategy and documents required for any regulatory submissions are shared with stakeholder in a timely fashion.
   1. Plan and prioritise variation submissions based on nature/criticality of change using information available (for example supply impact, compliance risk etc)
   2. Following up for documents from necessary stakeholders, reviewing documents to ensure it meets the regulatory requirements and address any gaps that may exist
   3. Preparation of regulatory submission with a focus on right first time; ensure internal review comments are addressed
   4. Coordination with stakeholders (publishing team, regulatory partner, internal stakeholders or health authorities) to ensure submission before due dates
   5. Following up on approval, prompt responses to any request for information ensuring timely approval and carrying out necessary post approval activities as defined in regulatory procedures
3. Ensure meeting other regulatory obligations like submission of Article 61 (3) updates, MAH Transfers, PSUR, Sunset clause applications as and when applicable, working cross functionally to get the necessary information for submissions and informing stakeholders about submission / outcome as per defined regulatory procedures
4. Ensure prompt action in terms of compliance to departmental procedures, ensure up to date training records for self, and regulatory databases are kept up-to-date as stipulated in  internal procedures
5. Participate in continuous improvement initiatives, sharing ideas and thoughts, actively involved in implementation of such initiatives
6. Act as process owners for some simple regulatory procedures as and when delegated
7. Support Line Managers for readiness of any health authority inspection as and when delegated
8. Ensure timely completion of assigned Deviation and CAPAs
9. Provide timely response to Cross Functional Teams

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