Regulatory Affairs Senior Manager

Location: Oxfordshire  |  Oxfordshire  |  England
Sector: Life Sciences
Consultant: Stewart McGrath
Job Reference: SM/HQ00000478
Salary: £70000 - £80000
Job Status: Permanent / Full Time

Job Description

When you’re part of the team you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Overview

Assist the Quality Director and the Qualified Persons in part of their duties relevant to Public Health Code governances to enable Site and Product Regulatory Compliance within the required timelines for both sites. Develop regulatory services (focus CTD Quality module 3 – Drug Product) within Commercial Operations for EU, US and RoW markets

Interactions: Internally, with various local functions such as business, technology transfer, EHS, finances as well as within the EU RA platform. Externally, with the UK authorities and Pharmaceutical Industry Associations

Technical: regulatory SME, sterile & non sterile dosage forms, condominium concept leverage

Financial: regulatory services annual revenues – 100 K€ (baseline)

Regulatory Expertise

Regulatory knowledge enhancement

Ensure UK regulatory surveillance (anticipate new directions, digest & disseminate, assist in implementation)

Increase overall regulatory knowledge (personal, quality, site) via trainings & communication tools development

Optimise key regulatory systems & tools (site and product related) – Data Bases, SOPs …

Address regulatory questionings (internally & externally)

Site Regulatory Compliance

Responsible for the maintenance of all official authorizations, domestic (MIA, IMP, ManA, GMP certificates, API registration, Controlled Drugs) and foreign (FDA e-establishment & drug product listing) including legalizations

Supervise the life-cycling of the SMF (PIC/S format)

Ensure inspections & key audits regulatory readiness (including support to compliance reports issuance) and/or participate (contribution to daily wraps)

Organize the recording & archiving of the official materials (establishment data base)

Product compliance

Responsible for the data collection, maintenance +/- optimization of the Customers’ registration information (CTD 3.2.P) data base

Ensure integration of registration information into Production and Quality master documents (process and QC specifications)

Responsible for the data collection, compliance check, uploading +/- optimization of the components (TSE, Residual Solvents, Elements Impurities, API GMP …) data base

Participate to the Change Control process by defining regulatory requirements

Regulatory Services

Deploy the regulatory services offering concept and implement process (including quotations & financial reporting) to capture business opportunities

Provide regulatory guidance (feasibility studies for new product introduction, strategy assessments)

Ensure projects regulatory liaison

Authoring or review & commenting of CTD Quality documents (gap analysis, IND-IMPD, NDA/BLA-MAA, registration questionnaires, pharmaceutical declarations) as per EU menu

Assist Customers products licences life-cycle activities (post approval changes, authorities deficiency letters/questions)

Regulatory Reporting: Deliver monthly and quarterly data for EU indicators compilation relevant to:

Site regulatory compliance activities

Product regulatory compliance activities (including compliance performance indicators)

Regulatory services and associated revenues

EH&S

Understand and ensure implementation of emergency procedures and safe systems of work.

Ensure compliance with environment, health and safety rules, signage and instructions at all times.

Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Observe safe working practices

Essential Requirements

Life Science first degree, e.g. in Pharmacy, Chemistry, or Microbiology, etc.

Regulatory knowledge: UK, EU, US & ICH core pharmaceutical regulations

Minimum of 10 years hands-on theoretical and practical regulatory affairs (including submission activities) in the field of medicinal products as well as regulatory compliance activities

Dynamic, self-motivated, pro-active approach to taking on challenging assignments

Creativity, judgement and analytical thinking

Ability to work with critical timelines

An excellent planner, who can envision short-term milestones which the company must achieve to succeed in the long-term

Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans

The drive and maturity to lead combined with the ability to support and interface effectively with projects and motivate cross-functional teams

Desirables

Former exposure to site activities

Knowledge of main international regulations (Brazil, Canada, Japan, Korea, Russia)

Cultural awareness

Regulatory basics on investigational medicinal products

Interacting with the MHRA

Post-graduate and / or professional body qualifications (TOPRA)

You will be working alongside the fastest growing recruitment company in the UK, who provide an unrivalled service to all of their clients and candidates across the United Kingdom. Seven currently offer the best contractor pay rates in the UK for Life Sciences, making us the best option for maximising your earning potential and career fulfilment. Seven Consultants are passionate about placing you in the best possible role, for the best possible rate, while providing a support platform, which is accessible around the clock.

Are you ready for the challenge? If so, we look forward to hearing from you.

What else can you expect from Seven?

– Specialist Consultant allocated to you with all the expertise you require.

– Excellent Payroll and Compliance System, ensuring that you are paid on time, every time.

– Access to Exclusive Rates, allowing you to gain earnings that no other agency can offer you.

– £250 Referral Bonus for every person you successfully refer to Seven.

If you are interested in this opportunity, please call 020 3887 7365. Please ask for Stewart McGrath in the Life Sciences team.