Regulatory Affairs Senior Manager

An international and leading biopharmaceutical company is currently recruiting a Regulatory Affairs Senior Manager to join their team in the UK. This is an excellent opportunity to bring your expertise and skills to an established and in-demand company that is is dedicated to developing life-changing medicines for people with limited or no options, so they can live their lives more fully and redefine what is possible.

Job Responsibilities:

• Managing registration and regulatory support for commercial and development projects worldwide.
• Managing regulatory activities to maintain EU and global commercial licenses.
• Supporting EU and global clinical trials.
• Supporting development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development, under the supervision of GRA leadership.
• Through the performance of risk assessments, working with GRA leadership to identify and communicate potential risks associated with strategy scenarios to the multi-disciplinary team.
• Acting as regulatory representative at meetings with business partners and regulatory agencies.
• Planning and coordinating the writing and reviewing for Module 2 CTD sections of regulatory submissions (IMPDs, CTAs, MAAs, meeting requests, and briefing documents), as appropriate.
• Coordinating the preparation and timely submission of responses to regulatory agencies.
• Managing timelines to ensure approvals are timely and development objectives are met.
• Monitoring Global regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
• Verifying electronic publishing of regulatory submissions.
• Identifying & support continuous improvement opportunities for the broader GRA team.
• Ensuring compliance with company policies, procedures and training expectations.

Skills and Requirements

• Bachelors, Masters or advanced degree in a scientific discipline.
• English language - written and verbal communication skills.
• Demonstrated understanding and strategic application of regulations and guidelines for drug development.
• Solid working knowledge of regulatory and ability to generate clear, well-argued positions.
• Must have experience with electronic Common Technical Document regulatory documents (MAA, BLA, responses and CTAs/INDs).
• Demonstrated understanding of EMA and ICH guidelines.
• Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency in computer skills, such as MS Office.
• Some travel required.
• Occasional public contact requiring appropriate business apparel.

Other - Physical Demands and Working Environment:

• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.
• Some travel required.
• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer use at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at 0203 869 2329 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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