Regulatory Affairs Associate

Company description

Rudipharm Ltd is a UK based pharmaceutical company that focuses generic medicines in various dosage forms. With over 100 MHRA licences, and many more to follow, we can offer excellent development opportunities within Regulatory Affairs but also other areas within the company.

This role will be office based (Maidenhead) with the flexibility to work from home on occasion. Rudipharm are not able to offer visa sponsorship at this time.

Job description

Due to significant growth, we are now looking for a Regulatory Affairs Associate to join our team.

Main responsibilities:

• Assist with the preparation and submission of applications of reliable quality in a timely manner to MHRA (UK) via National Procedure. These include new licence applications, variations (including grouping and work sharing), renewals, artwork changes, RFIs, updates and any other relevant applications or notifications.
• Work with QPPV on PSUR submissions, update SmPC and labelling in line with the Company Core Data sheets.
• Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
• Carry out duties in line with regulatory, commercial, quality and business needs and ensure compliance with regulatory legislation and guidelines, and company processes and procedures.
• Perform batch release
• Perform internal audits

Required Attributes:

• Must have a 2:1 or above in either a Pharmacy, Chemistry or similarly analytical related degree
• 1 years’ experience in the pharmaceutical industry or related field although graduates are welcome to apply
• A basic understanding of the current UK and European regulations, laws, guidelines and industry requirements is preferable but not necessary.
• High attention to detail to ensure the quality of documentation.
• Strong interpersonal and communication skills; ability to develop and maintain cooperative working relationships with others and work in a team-based environment

Job Types: Full-time, Permanent

Salary: £28,000.00-£32,000.00 per year

Benefits:

• Company pension
• Gym membership
• On-site parking
• Work from home

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Maidenhead SL6 2RB: reliably commute or plan to relocate before starting work (required)

Experience:

• Regulatory (Pharma): 2 years (required)

Work Location: Hybrid remote in Maidenhead SL6 2RB