Senior Regulatory Affairs Manager - UK and Ireland
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Proclinical are recruiting for a Senior Regulatory Affairs Manager - UK and Ireland to join a pharmaceutical organisation. This role is on a contract basis with the ability to work remotely.
- Monitor external vendor/contractor relationships where suitable.
- Oversee the external regulatory setting to aid notify/advise in the regulatory decision making.
- Serve as the main point of contact with regulatory agencies in fulfilling local obligations.
- Contribute/partake in local agency interactions and their preparation.
- Guarantee regulatory proposals are made to meet the business's corporate and local regulatory needs in a timely manner.
- Evaluate and approve both the promotional and non-promotional materials.
- Support the healthcare compliance actions that are local where suitable.
- Produce, evaluate and approve source text for country labelling, and owns the country artwork based on source text.
- Contribute to local regulatory process improvements, initiatives and training.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level with exhaustive regulatory experience and/or linked to the country(ies).
- Know-how of country(ies) legislation and regulations linking to medicinal products.
- Expertise on regulatory principles.
- Operate with policies, procedures and SOP's.
- Understanding of regulatory actions and how they impact other projects and/or procedures.
- Know-how of national legislation and guidelines linking to medicinal products.
- Conscious of the registration processes/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
- Expertise on the local regulatory setting for product area and development stage.
- Comprehension of drug development.
- Capable of forecasting regulatory agency questions and possible replies.
- Works well in a team.
- Communication skills both verbally and in writing.
- Deliberation and influential abilities.
- Able to resolve issues.
- Cultural awareness and sensitivity to accomplish objectives across both regional, country and global borders.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall on firstname.lastname@example.org.
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.