Sr Mgr, RA – Topical Pain – Rx to OTC
Consumer Healthcare’s Pain Category delivers innovation for leading brands of global pain relief remedies globally.
Our client currently have a Category Regulatory Affairs Senior Manager vacancy within our global Pain category regulatory team in the USA, to partner with a cross-functional team to deliver an ambitious R&D innovation program, and support the global objectives of the regulatory affairs team.
The purpose of this role is to provide regulatory support to assigned products/projects or parts of projects to enable our products to be successfully introduced or maintained Globally.
In this role the individual is likely to support other members of the functional team but may also work in Project Teams and build trusting relationships with multi-functional teams within the sub-category and with the Local Operating Companies to ensure all regulatory requirements are met for both new innovation and existing products according to values.
– Acts as a Business Partner and provides regulatory advice to a project on aspects of drug/ device development as appropriate.
– Develops regulatory strategies working within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams.
– Communicates effectively with the immediate functional team and within cross-functional Project Teams.
– Delivery of high quality regulatory files to agreed timelines
– Inputs to non-product related activities both within the function in order to direct new policy or pioneer new processes or improvements to competitive advantage.
– In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc with supply chain and technical excellence Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions.
Behavioral Skills & Competencies:
-Skilled organizer and communicator due to the complex mix of internal and external relationships.
-Can work independently with senior external stakeholders, with ability to represent category position and make necessary decisions without constant reference to center.
-Ability to manage in a network/matrix (i.e. to co-ordinate activities of a wide range of staff/disciplines with no direct reporting line) to achieve and operate to consensus.
-Driven, self-reliant and flexible, with excellent time management skills and an ability to work in an empowered environment.
-Sound influencing and negotiating skills.
-Track record of influencing change.
-Demonstrated ability to apply sound scientific principles, techniques and decision making in driving their assigned programs.
-Able to create business solutions.
-Responsible for highlighting own development needs and work with his / her manager to prepare a development plan and achieve development goals.
-Substantial record of achievement in previous role/s.
– BS/BA degree in a scientific discipline
– 8 year experience within Regulatory Affairs.
– Extensive knowledge of US regulations
– Extensive knowledge of US regulations for OTC/Rx drug products.
-Experience with Rx-to-OTC Switch regulations.
-Ability to interpret and understand government regulations
– MS/Ph D/Pharm D/JD
– Significant experience with US Rx-to-OTC switch, including preparation for
– Understanding of US IND process for OTC/Rx drugs
– Working knowledge of international regulations (OTC medicinal) governing
classification, composition, labeling and claims
– Ability to lead cross-functional teams in regulatory submission creation.