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Senior / Regulatory Affairs Consultant - Clinical Labelling

Parexel International Corporation

United Kingdom - Any Region - Home Based

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

This role can be either office based in Uxbridge or Dublin or you can be fully home based anywhere in the UK or Ireland respectively. The offices are open planned, and you will be working in an innovative and collaborative environment connecting with colleagues from around the world. This role can also be office based or home based in the following countries: Hungary, Croatia, Belgium, Netherlands, Italy, Spain, Lithuania , Poland, Russia, Serbia, Switzerland, Turkey, Ukraine, Czech Republic or Romania.

As the Senior / Regulatory Affairs Consultant -Clinical Labelling (dependent on experience level ) you will have a comprehensive understanding of the organization’s consulting models and methodologies, as well as a good knowledge of what services the group provides. You must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. You will also ensure the timely performance of work within a project scope to the quality expectations of the group and the client.

This Senior / Regulatory Affairs Consultant (Clinical Labelling) position will be an SME and specifically focus on driving the core labelling strategy and ensure that labelling documents are of high quality and compliant for the safe and effective use of our products for patients and healthcare providers globally. You will be responsible for overseeing and supporting the development and update of core labelling documents and for tracking implementation at a regional and global level.

Key Accountabilities:

Project Execution

- Typically works within a team environment but may work independently delivering services within their technical area of expertise (labelling)

- Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts

- Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes

Consulting Activities and Relationship Management

- Follows and implements the organization’s consulting models and methodologies

- Provides technical and/or business consulting services within personal area of expertise (Labelling)

- Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability

- Collaborates with colleagues and client to identify and resolve technical and process issues

Business Development

- Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience

- Communicates potential new business leads to management and account managers

- May participate in project scoping calls and/or proposal preparation with the support of senior colleagues

Labelling related responsibilities

- Oversee the creation and authoring of core labelling documents (you will be acting as the Lead on this)

- Oversee regional implementation and strategy

- Devise Core labelling support documentation and Quality Check the work of the group

- Maintain and manage labelling complianceQualificationsEducation:-

- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline,

- Advanced degree preferred; - MSc or PHD

Skills:

- Project management knowledge

- Clinical Writing skills

- Client-focused approach to work

- Results orientation

- Teamwork and collaboration skills

- Consulting skills

- Excellent interpersonal and intercultural communication skills, both written and verbal

- Critical thinking and problem-solving skills

- Proficiency in local language and extensive working knowledge of the English language

Essential Skills and Experience:

- Previous experience working in CRO, Pharma or a Regulatory agency in the capacity as a Clinical Labelling SME or Clinical Labelling Regulatory Affairs Consultant / Senior Regulatory Affairs Consultant with a a keen desire and dedication to on Clinical labelling

- Ability to summarize regulatory guidelines and apply them appropriately;

- Strong understanding of regulatory lifecycle maintenance activities (labelling and clinical) across EU and ROW markets

- Change Control assessment experience or transferable skills (application of relevant regulatory guidance to proposed change)

- Needs experience in: authoring or Quality Checking CTD clinical documents, PSUR updates, management of CCDS updates and submission experience of simple and complex labelling variations to EU markets

- Capable of participating in discussion on regulatory strategies with a wide stakeholder network (Global Labelling, Supply, Brand Leads etc.)

- Critical thinking and problem-solving skills;

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus and benefits package including days holiday and other leading edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!

Job posted: 2021-12-08

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