Regulatory Affairs Associate

hampshire, england, United Kingdom

The candidate must have UK level submission experience.

The purpose of the Regulatory Affairs Associate/Senior Associate role is to manage the operational and technical aspects of regulatory affairs for the UK and Ireland marketing affiliate and the Maltese marketing affiliate, including:

Execute the Regulatory Plan/objectives to ensure the success of new product registrations, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements

Foster an environment of operational excellence and collaborate with cross functional teams to successfully achieve affiliate regulatory objectives

Facilitate and cultivate relationships with the local regulatory agencies and trade associations

Primary Responsibilities:

Regulatory Plan Execution

Implement the Regulatory Plan in alignment with affiliate business plans as well as with regulatory requirements.

Ensure submission and approval of high quality regulatory applications within planned timeframes. Maintain or support maintenance of clear metrics for regulatory deliverables.

Preparation and support of new applications to obtain marketing authorisations

Voicing affiliate perspective and needs to global and regional regulatory contacts

Ensuring timely responses to requests from support groups and/or regulatory authorities

Maintaining marketing authorisations (timely submission of post-approval maintenance activities like renewals, variations and periodic reports)

Maintain regulatory tools in alignment with defined compliance metrics

Support affiliate launch teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plans

Represent the regulatory affairs function as appropriate in brand teams and New Product Planning discussions

Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally

Facilitate interactions with regulatory bodies on a regular basis

Support the implementation of any additional risk minimization measures at the affiliate and ensure appropriate metrics are generated

Labelling

Perform the function of Primary, Delegate or Alternate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or regulatory authority timeframes

Follow global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product Information which is in compliance with global core labelling

Regulatory Compliance

Ensure that internal regulatory IT tools and trackers are up to date and accurate

Ensure that all products comply with local regulations and quality system requirements whichever is more stringent

Ensure that the regulatory archive is complete and up to date and ensure that all current licenses and labels are readily available

Support internal audits / assessments / self-inspections / external inspections in collaboration with Medicines Quality Organisation and local Ethics and Compliance

Implement corrective/preventative actions as appropriate

Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions

Support implementation of local quality system in line with the global quality system and local regulations

Process Improvement

Ensure alignment and implementation of internal regulatory initiatives

Actively participate in affiliate cross-functional teams and provide regulatory input and knowledge

Support implementation of launch readiness initiatives

Build and maintain relationships with key regulatory officials and trade associations

Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives

Personal and Professional Development

Knowledge and understanding of local regulations and local, regional and global regulatory procedures

Attend appropriate external symposia, workshops or conferences to develop technical expertise

Minimum Qualification Requirements:

Bachelor's degree or equivalent in a relevant scientific subject

At least one year industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needs

Team working skills with special focus on results

Ability to adapt to challenging situations

Demonstrated good computer/IT skills

Good knowledge of written and spoken English

Other Information/Additional Preferences:

Analytical, problem solving and negotiation skills

Good communication skills

Project management skills

Strong planning and priority setting

Good capability to establish positive networking both internally and externally (e.g. trade associations)

Knowledge of Quality systems

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

Proclinical Staffing is an equal opportunity employer.