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Regulatory Affairs Consultant Safety/Labelling

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Poland

Offer summary

Qualifications:

Bachelor’s Degree in Scientific or Technical Discipline, 3-5 years of experience in industry-related environment, Experience in pharmaceutical industry Global Labelling, Experience in Regulatory (Clinical/Safety) role, Knowledge in interacting with regulatory authorities.

Key responsabilities:

Act as expert for labelling activities
Provide strategic labelling guidance and input
Develop and review labelling and safety-related content
Create and maintain CCDS, lead updates
Advise on regulatory requirements for labelling updates

Parexel Pharmaceuticals XLarge http://www.parexel.com/

10001 Employees

See more Parexel offers

Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a Regulatory Affairs Consultant - Safety/Labelling to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.

Key responsibilities will include:

Acting as expert for labelling-related activities
Providing strategic labelling guidance and/or input in regulatory impact assessment, submission preparation and execution
Developing, supporting and reviewing labelling and/or safety-related content
Creating and maintaining the CCDS; leading and coordinating CCDS updates, coordinating and overseeing the implementation of updates into local labels
Advising on the regulatory requirements for labelling updates in different global regions e.g. EU and ROW.
Experienced in managing responses to regulatory authoring questions and negotiating company positions with regulatory authorities

Skills and experience:

Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
3-5 years of experience in an industry-related environment
Previous experience working in the pharmaceutical industry in support of Global Labelling or in a Regulatory (Clinical / Safety) role
Experience interacting with a regulatory authorities
Critical thinking and problem-solving skills
Project leadership and management knowledge
Excellent interpersonal and intercultural communication skills, both written and verbal