Regulatory Scientist

ZipRecruiter; Bracknell; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A leading pharmaceutical client is seeking a Regulatory Affairs professional with European Regulatory experience for a hybrid contract role in Bracknell. The ideal candidate will manage regional regulatory submissions and ensure compliance with local regulations. Requires a Bachelor's degree in a scientific discipline and 1-3 years of relevant experience. Strong communication and teamwork skills are essential. Please submit your updated CV, noting no visa sponsorship is available.

Qualifications

• 1-3 years of industry-related or relevant work experience.
• Knowledge of the drug development process.
• Ability to work independently and assess risks.

Responsibilities

• Provide input and review of global submission documents.
• Ensure compliance with regulations and quality systems.
• Support development of local/regional labelling strategy.

Skills

Regulatory submissions

Local regulatory procedures

Teamwork

Communication skills

Negotiation skills

Education

Bachelor’s degree in scientific or health sciences discipline

Job description

Job Description

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.
• 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 , equity and 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***