Manager Regulatory Affairs/Compliance

Manager Regulatory Affairs/Compliance focuses on preparing and submit new marketing authorisation applications (maas) supporting international countries within the emerging markets region.

What the role involves

• Preparing and submit new Marketing Authorisation Applications (MAAs) supporting international countries within the Emerging markets region.
• Supporting global expansion through the submission of registration dossiers for existing products.
• Leading dossier remediation activities, including aligning legacy registrations with current regulatory requirements to enable geographic expansion.
• Supporting lifecycle management of marketed products, including Variations, Renewals, and PSURs.
• Liaise closely with local Regulatory Affairs affiliates on regulatory documentation, including labelling, variations, and new registrations.
• Provide hands‑on support for country‑specific labelling requirements.

Skills and requirements

• Degree‑qualified in a Life Sciences discipline or related field.
• Minimum 5 years’ experience supporting international regulatory markets.
• Proven experience managing new MAAs, global expansion of existing products, and extensive lifecycle maintenance (essential).
• Experience working closely with international Regulatory Affairs affiliates.