WALKER COLE INTERNATIONAL LTD
Walker 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
To apply for this job please visit www.reed.co.uk.
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