- Preparation and elaboration of "ready to submit" dossier for renewal, labeling changes, post approval changes, new registration* according to local requirements.
- Elaborate and follow up dispatch plan and submission plans.
Leadership
a) Develop and maintain excellent relationships with GRA platforms and affiliates to ensure optimal stakeholder management and affiliate support.
b) Monitor regulatory environment to identify potential future changes and ensure impact to business is communicated to relevant local and GRA contacts.
c) Develop and update knowledge of the legislation of countries in charge.
Dossier elaboration for Regulatory Submissions
a) To undertake all necessary dossier elaboration, evaluation and timely dispatch for regulatory submission in accordance to local regulations with agreed business priorities to ensure compliance of all assigned products in the given cluster of countries.
b) To assist with development of optimal regulatory strategies in collaboration with key internal stakeholders to drive early submission and approvals in accordance with agreed business priorities.
c) Keep up-to-date with developments in regulatory affairs and assist with implementation of any required revisions to systems and processes.
d) Contribute technical support to the areas of quality control and technical product development regarding the dossiers sent to the region to progressively improve the quality of our dossiers in a way that conforms to the regulatory guidelines.
e) Ensure the quality of files sent, avoiding or decreasing, the number of observations of the from Health Authority, in order to avoid delay in the processing times.
f) Ensure the follow up and traceability of the regulatory process concerning the dossiers sent, submitted and records obtained, in the different countries.
g) Manage the response of deficiency letters from HAs of the countries in charge (review information, coordinate times of response)
h) Ensure the delivery of the dossier to the affiliate, with risk assessment without impacting the dates of submission.
i) Ensure the answer to the requirements of the affiliates and authorities of the regulatory agencies on time.
j) To assist in regulatory activities needed to maintain marketing authorisation in the cluster responsible.
k) Coordinate translation of the dossiers when required according to the local legislation.
Manage and track activities
a) Keep track of submissions/renewals and variations(including annual reports), sent to the region.
b) Provide accurate and timely information to ensure regulatory database is updated.
c) Ensure timely dispatch, tracking and archiving of dossier to the countries in charge and global database/repository where applicable.
