Remote Senior Regulatory Affairs Specialist

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 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.