Manager,Global Regulatory Strategy - RII TG

We are seeking a talented individual with regulatory affairs knowledge/experience and interpersonal skills to join our RII TG, Global Regulatory Strategy team.

As a valued member of the Regulatory Matrix Team and the asset project teams, you will be empowered to develop appropriate regional regulatory strategies and ensure their execution for assigned assets. This will be consistent with the Medicines Development Strategy/Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile and secures the best possible labelling commensurate with the available data.

Key Responsibilities:

• Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking into account the needs of other regions globally.

• Implement the regional strategy(s) in support of the project globally

• Lead regulatory interactions and the review processes in local region

• Ensure appropriate interaction with global/regional counterparts and commercial teams in local region

• Ensure compliance with global/regional requirements at all stages of product life

• Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset

Basic Qualifications:

• Bachelor's degree in Biological Sciences, Healthcare Sciences, or a related field required; advanced degree (e.g., PhD) preferred.

• Minimum of 1 year experience in the drug development process within regulatory affairs.

• Minimum of 1 year experience managing development, submission, and approval activities in different regions globally.

• Minimum of 1 year of experience implementing clinical trial requirements in at least one region (EU or US).

Preferred Qualifications & Skills:

• Knowledge of clinical trials and licensing requirements in all major countries in the region and ideally knowledge of other key agency processes globally.

• Experience in Respiratory therapeutic areas.

• Good communicator who can deliver key communications with clarity, impact, and passion.

• Strong listening and comprehension skills, with the ability to proactively identify potential issues and escalate as required.

• Proficient in digital tools and systems to enhance project delivery and drive efficiency and innovation.

• Ability to foster collaborative working relationships and work effectively within cross-functional teams.

Work Arrangements:

This role offers a hybrid working model (Performance with Choice; 2 to 3 days), fully home-working/remote work arrangements are not available for this role.

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