Regulatory Affairs Head

321036BR
Sep 02, 2021
Romania

Job Description

11,000 associates are working in Global Drug Development at Novartis.
Would you like to be part of our dynamic Regulatory Affairs team?
The RA Head leads the country regulatory team and has the overall accountability for regulatory activities within the Country Pharma Organization (CPO), in line with the local, regional and global strategies while ensuring alignment and collaboration across Novartis divisions and line functions. The RA Head for Romania provides effective regulatory support to Romania Country and global organisations for assigned product development and maintenance, including input into regulatory strategy, handling submissions and follow up of clinical trial authorisations, marketing authorisations, their maintenance and life cycle management.

Your responsibilities:

Related to assigned products/portfolio and RA team
•Ensures alignment & collaboration with RA GDD across all Novartis divisions as part of the Global Drug Development (GDD) working model and in line with the local, regional and global strategies.
•Ensure high-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA), line extensions and life cycle sub-missions.
•Coordinates translations for centrally approved products ensuring timely and quality results, artworks preparation, information flow between RA and other departments, cooperation between RA, QA and distribution chain.
•Working closely with global and local colleagues cross-functionally to advise and agree on regulatory strategy, clinical development plans and data requirements. Participation in regional RA sub-teams.
•Where applicable, organizes and participates in Health Authority scientific advice meetings with global teams to support product development programs.
•Ensures submissions (including RMPs and PSURs) are made in accordance with accepted regulatory standards within appropriate and agreed timeframes.
•Creates and maintains the country specific part of dossier including official local drug information.
•Ensures proper archiving of all documents submitted to the Health Authority and related correspondence
•Monitors and influences assessment process to expedite and optimize the outcome of the submissions. Drive negotiations with Health Authority to ensure best possible product labelling and delivery of their commitments and deadlines.
•Works closely with local brand teams to ensure launch readiness plans are in place in order to successfully launch products.
•Proactively monitors status of post-approval commitments made to Health Authority and ensures their timely completion. Contribute to the brand Risk Management Plan according to needs.
•Works closely and swiftly with cross functional teams in case of critical issues, e.g. related to batch recall or other batch release issues.
•Demonstrate strong and visible support for the pharmaceutical quality system and ensure the implementation throughout their organization to meet quality objectives.
•Leads, motivates, sets objectives and manages performance of the team to assure completion of organizational goals, in a diverse and inclusive environment.
•Ensures functional competence by development of staff to improve their individual and team performance (eg. coaching, thorough performance reviews, development planning, etc).
•Ensures proactivity and collaboration for successful engagement with internal & external stakeholders.

Regulatory Intelligence & Policy
•Represents Novartis at local Pharma Trade Association bodies for regulatory relevant agenda

Minimum Requirements

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Global Drug Development
REG AFFAIRS GDD
Romania
Bucharest
Research & Development
Full Time
Regular
No
321036BR

Regulatory Affairs Head

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