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Manager Regulatory Affairs
Systemic Pain Category
Industry Leading Company
About Our Client
International industry leading consumer care company
In this role the individual will build a network of collaborative relationships within the sub-category and LOCs and ensure all regulatory requirements are met for both new innovation and existing products according to company Values. In this role an individual may also manage a small team for which they will set a compelling vision and deliver against the sub-category strategy and mission. The role may require the individual to provide specialist regulatory advice across the Category and Function.
- Acts as a Business Partner and provides regulatory advice across a brand or subset of products on aspects of drug/cosmetic/devices/food and supplements (dependent on category) development and regulatory requirements as appropriate.
- Develops novel regulatory strategies and influences approaches within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams.
- Communicates effectively within the function at all levels and within cross-functional Project Teams.
- May supervise or mentor other team members. Plans, prepares and delivers high quality regulatory files to agreed timelines
- May lead non-product related activities within the function and input cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage.
- May act as representative to external groups on specific task forces within their field of expertise.
- Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Project Team.
- 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.
The Successful Applicant
- Significant experience with US consumer drug products.
- Experience with the OTC drug monograph process, OTC label review, review of promotional materials Working experience with OTC drug product listing, Certificates of Pharmaceutical Products and Import/Export regulatory issues
- Understanding of IND process for OTC drugs
- Ability to interpret and understand government regulations.
- Ability to prioritize team activities and issues.
- Understanding of Drug Product Listing, Certificates of Pharmaceutical Products and Import/Export regulatory issues
What's on Offer
Competitive salary, bonus, stock options and relocation if necessary