Drug Regulatory Affairs Manager
Lead the Global Regulatory Project Team, which may include members internal to Covalent , or external, from an outsource provider or licensing partner.
Lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex regulatory maintenance/ divestment/ withdrawal submissions and response documents from either a global and/ or regional perspective. This will include:
the maintenance of core labeling documents including the Core Data Sheet, and Core Patient Information Leaflet, including labelling history documents.
the maintenance and corporate approval of EU SmPC and US PI and packaging component labeling while ensuring consistency with applicable core labeling documents and internal standards and SOPs.
Ensuring that updates to the core texts are completed, communicated to and implemented by MCs in a timely manner and deviations are agreed and documented appropriately.
Liaise proactively with the internal functions and external partners and lead cross-functional delivery teams for complex submissions, providing expert regulatory advice.
Identify potential complex regulatory risks to the operational plans, and propose options to mitigate risks.
Support Global Regulatory Lead or assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product maintenance/ divestment/ withdrawal program
Serve as the delegate, where appropriate, for the Global Regulatory Lead.
Provide coaching, mentoring and training within your Regulatory team/ department.
Ensure that appropriate, up-to-date records are maintained for compliance, including maintaining repositories of current regional labeling and ensuring proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents, .
Develop and maintain strong partnerships with internal and external customers and partners
Minimum Requirements Education and Experience:-
University Degree in Science or related discipline
6-12 years relevant regulatory experience, including license maintenance, labelling and publishing of working across a range of markets, including regulated markets
Thorough knowledge of the regulatory product maintenance process
Leadership skills, including proven leadership of cross-functional project teams experience
Excellent English written and verbal communication skills
Thorough scientific knowledge sufficient to understand all aspects of regulatory issues
Experience of working with people from locations outside of India, especially Europe and/ or USA
Skills and Capabilities:-
Supplier and Partner management & Knowledge sharing
Project management, Influencing, Problem solving, Independence, Team working, Customer focused
Understanding of the importance of Continuous Improvement.
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