Senior Regulatory Affairs Associate

PE Global International; Cambridge; Hybrid; GBP 44,000 - 47,000; Full time

Job summary

PE Global International is seeking a Senior Associate Regulatory Affairs for a leading multinational Pharma client, based in Cambridge. The role is a 12-month contract with monthly meetings in Cambridge and a largely work-from-home setup.

The candidate will manage regulatory strategies for one or more products, supported by a Regulatory Lead, and may lead planning and execution of programs. Visa sponsorship is not available.

Qualifications

• Master’s degree in a scientific area or a Bachelor’s degree with 2 years related experience.
• Knowledge of regulatory principles.
• Experience with policies, procedures and SOPs.
• Understanding of drug development and regulatory activities.
• Ability to communicate scientific/clinical information.

Responsibilities

• Align local regulatory requirements with company standards and regulatory expectations.
• Provide input to and execute regulatory strategies for local/regional submissions.
• Plan and manage local regulatory submissions in line with corporate standards and local rules.
• Guide on mechanisms to optimize product development and approvals.
• Ensure local labels are developed and maintained per legislation and standards.
• Support local regulatory product compliance (e.g., IMR, PMCs, agency commitments).
• Act as main contact with regulatory agencies.
• Ensure submissions are timely and compliant with requirements.
• Create/review country labeling texts and own country artwork.
• Coordinate with Regional/Global Study Operations to support local planning for studies.
• Review and approve promotional and non-promotional materials.
• Monitor regulatory environment to inform decision making.

Skills

Regulatory knowledge

SOP adherence

Scientific communication

Regulatory submissions planning

Education

Master’s degree in a scientific field

Bachelor’s degree in a scientific field with 2 years related experience

Job description

PE Global is currently recruiting for a Senior Associate Regulatory Affairs for a leading multi-national Pharma client based in Cambridge.

This is an initial 12 months contract position with potential for extension.

Pay rate is £22.33ph PAYE or £30.13ph Umbrella.

Working mainly from home but would be expected to go in for team meetings (once a month in Cambridge).

The Senior Associate Regulatory Affairs is assigned to one or more company products and may support an LRR or lead the planning and execution of Regulatory strategies for a program(s) under the supervision of an experienced Regulatory Lead.

Duties of the role/Responsibilities

• Assist in aligning local regulatory requirements with company’s corporate standards.
• Provide national/regional (as applicable) input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Provide guidance on local mechanisms to optimize product development and regulatory approvals
• Ensure local labels are developed and maintained in line with local legislation and company standards and procedures.
• Ensure and support local regulatory product compliance (eg, IMR, PMCs, and agency commitments)
• Act as the point of contact with regulatory agencies.
• Ensures regulatory submissions are made on time and meet company’s corporate and local regulatory requirements.
• Creates, reviews, and approves source text for country labeling, and owns the country artwork based on source text.
• Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
• Reviews and approves the promotional and non-promotional materials
• Monitors the external regulatory environment to help inform/advise in the regulatory decision making.

Education/Experience

• Master’s degree (scientific area) OR
• Bachelor’s degree (scientific area) and 2 years of directly related experience
• Knowledge of Regulatory principles.
• Working with policies, procedures and SOP’s.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• General knowledge of national legislation and regulations relating to medicinal products.
• Understanding of drug development.
• Ability to understand and communicate scientific/clinical information.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***