Senior Regulatory Affairs Associate

Scienceabode; Cambridge; Hybrid; GBP 60,000 - GBP 80,000; Full time

Job summary

A global pharmaceutical company is seeking a Pharmaceuticals Regulatory Affairs Associate to support regulatory strategies for drug products. The role involves managing product portfolios and ensuring compliance with UK and Ireland regulations. Ideal candidates should have a relevant degree and experience in regulatory submissions. This position offers a hybrid working model, with the option to work from home or on-site in Newbury for the remainder of the contract, which is initially for 12 months.

Qualifications

• Experience in product labelling activities and regulatory drug submissions.
• Familiarity with Windsor Framework compliance.
• Ability to compile regulatory documents for submissions.

Responsibilities

• Support regulatory strategies for assigned product portfolios.
• Manage local Regulatory Affairs activities.
• Assist in preparation and review of labelling and local SOPs.

Skills

UK and Ireland drugs regulatory labelling requirements

Regulatory Authority submissions

Excellent project management skills

Computer skills (Word, Excel, Power Point, Outlook)

Good project management experience

Education

Bachelor’s degree or equivalent in a relevant scientific discipline

Job description

Pharmaceuticals Regulatory Affairs Associate – Homebased and Office

Opportunity:

This is a great opportunity for a Regulatory Affairs (RA) Specialist to develop your career in regulatory affairs for drug products.

Do you have experience in product labelling activities and regulatory drug submissions? Do you have experience of the Windsor Framework compliance? Have you compiled regulatory documents for submissions within the UK and Ireland? Looking for a contract role with an exciting global pharmaceutical company? If yes then this is the role for you.

Your role as a Pharmaceuticals Regulatory Affairs Associate will involve supporting regulatory strategies for assigned product portfolios and performing life cycle management submissions for medicinal drug products. You will manage local Regulatory Affairs activities and help support business product launches and tender applications mainly for the UK and Irish markets.

Duties and responsibilities include:

• Supporting and maintaining pharmaceutical product portfolios.
• Managing ongoing product information updates for Windsor Framework compliance.
• Supporting regulatory project plan execution.
• Assisting in preparation and review of labelling and local SOPs.
• Maintaining awareness of regulatory requirements relating to UKI regulations.
• Compiling regulatory documents for submission.
• Maintaining internal product information databases (e.g. RIM Vault) and change controls.

This is a 12 months contract role which will be reviewed for a possible extension or go permanent however this is all dependent on the individual and business performance. This is a role based working from home 3 days a week and to attend the office 2 days a week which is located in Newbury, Berkshire. There is also the option to be on site every day. The client will also be flexible with 5 days a week working from home.

The PAYE rate is £30.50.

Skills:

To apply for role of Pharmaceutical Regulatory Affairs Associate you will have the following:

• Bachelor’s degree or equivalent in a relevant scientific discipline with experience of UK and Ireland drugs regulatory labelling requirements, Regulatory Authority submissions and Regulatory Authority communication/negotiation.
• Excellent project management skills.
• Computer skills (Word, Excel, Power Point, Outlook, corporate software).
• Good project management experience.

How to Apply:

To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat.