Full job descriptionWalker Cole International is supporting a growing speciality pharmaceutical/OTC consumer healthcare company in the search for a Senior Regulatory Affairs Manager.
The Senior Regulatory Affairs Manager is responsible for leading and managing the regulatory affairs activities the product portfolio, ensuring compliance with UK & EU regulatory requirements. The role supports the development and execution of regulatory strategies, manages marketing authorisation lifecycle activities, and acts as a key liaison with regulatory authorities, partners and internal stakeholders.


Key Responsibilities
*Develop and implement regulatory strategies to support commercial objectives and product lifecycle management.
*Manage regulatory submissions including new Marketing Authorisation Applications, Variations/Notifications, Renewals
*Ensure timely maintenance of Marketing Authorisations across all applicable territories.
*Manage post-approval regulatory activities across the product portfolio.
*Act as a primary contact for MHRA and other regulatory authorities for assigned products.


About You
*Degree in Pharmacy, Life Sciences, Chemistry, Regulatory Affairs or a related scientific discipline.
*Minimum 5 years of experience within pharmaceutical Regulatory Affairs.
*Significant experience managing UK and EU Marketing Authorisations.
*UK and EU pharmaceutical legislation
*MHRA and EMA regulatory requirements
*Experience managing regulatory submissions and lifecycle activities.
*Experience interacting with regulatory authorities and external partners.


Regulatory Affairs / Senior Regulatory Manager / Lifecycle Management / Variations / Renewals / MHRA / EMA / International Regulatory Affairs / Pharmaceutical Industry / OTC / Consumer Healthcare