Full-Time Regulatory Affairs Director
Descrizione Lavoro
Reference: RADN6962
Job Summary:
Here at IOmet Pharma Ltd we have great opportunity for a Regulatory Affairs Director to join a truly global biopharmaceutical company. This role will be based in United Kingdom
Requirements:
As Regulatory Affairs Director, you will be part of the Leadership Team contributing to the overall success of our UK business through regulatory activities.
Job Role:
The Regulatory Affairs Director job role will include some key accountabilities that are:
– Defining regulatory strategy for marketed products in line with commercial and company strategy, consulting with appropriate departments where necessary.
– Representation of regulatory affairs at team meetings
– Manages the maintenance of FDA approvals (NDAs, BLAs etc.) in compliance with relevant regulatory legislation and guidelines.
– Ensure the preparation, review and approval, submission and management of regulatory submissions (paper and electronic) in compliance with the relevant legislation or guidelines and within timelines agreed with management or defined by legislation; ensuring the monitoring and facilitation of progress.
– Review advertising, promotions and other related materials for assigned products to ensure compliance with applicable FDA laws, regulations and guidance.
– Management and approval (and distribution as appropriate) of core regulatory documents such as Prescribing Information.
– Stay abreast of all relevant regulatory and industry changes and updates related to FDA guidance, warning letters, enforcement actions and regulations and communicate to appropriate internal and external personnel in a timely manner, highlighting the implications of the changes.
– Management of the preparation, attendance and follow-up of meetings with Regulatory Agencies including the generation of briefing documents and minutes.
– Provide support for regulatory activities associated with due diligence for in- and out-licensing activities.
– Management of the provision of information requested by regulatory authorities.
Qualifications and Experience:
A life Sciences graduate, with significant experience in regulatory affairs gained within the pharmaceutical industry, you will demonstrate expert regulatory knowledge and cross-functional working relationship skills, to include excellent negotiation, verbal and written communication and interpersonal skills. You will have the ability to understand and present complex scientific arguments and be a strategic thinker with the ability to develop global regulatory strategy whilst balancing local/affiliate needs.
