Regulatory Scientist

20 hours ago

Bracknell Berkshire, United Kingdom PE Global Full time

PE Global are currently recruiting for a Regulatory Affairs with European Regulatory experience for a contract role with a leading multinational Pharma client, based in Bracknell - hybrid. The GRA-EMEA or GRA-Americas Regional Regulatory Scientist is accountable to provide regional regulatory expertise in supporting the delivery of high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s). Responsibilities Provide region/country input and review of global strategic plans and global/regional submission plan and documents. Provide support to Regional Regulatory Lead Scientist during key governance committees on regional regulatory strategy decisions, if requested (e.g. when key discussion topics impact the region). Ensure approval and delivery of content for local regulatory submissions, engaging cross functional partners in contributing to development of submission content. Provide support to Regional Regulatory Lead Scientist for meetings and interactions with regulators in assigned region and engage cross functional partners to contribute to regulator interactions. Support development of local/regional labelling strategy (product information and packaging) and help to network for alignment across region/affiliate team to enable timely completion of registration milestones (i.e. submission, approval, and launch). Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling in region/country. Provide support to Regional Regulatory Lead Scientist in leading team during negotiation with regulators by providing responses to labelling questions. Ensure compliance with all applicable regulations and internal quality systems. Provide up-to-date expertise on regional registration procedures. Interpret and anticipate impact of new guidelines and work with Regional Regulatory Lead Scientist to initiate change in response to changing environment. Own all regulatory activities in support of assigned marketed product(s) in the region/country. Ensure the registration needs for local patients in clinical trials are met for countries in the region/country. Requirements Ideally someone with CTA experience + scientific advice or PIP or marketing authorisation or post-approval. Clinical experience is a must. Bachelor’s degree in scientific or health sciences discipline Industry-related or other relevant work experience in 1-3 years Knowledge of local/regional regulatory procedures and practices Knowledge of the drug development process Ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes Ability to assess and propose ways to manage risk in a highly regulated environment Demonstrated strong written, spoken and presentation communication Developing negotiation and influence skills Demonstrated attention to detail Demonstrated ability to work independently Interested candidates should submit an updated CV. ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

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