Senior Regulatory Affairs Manager

Location: Swindon  |  Wiltshire  |  England
Sector: Life Sciences
Consultant: Harvey Havell
Job Reference: HH/HQ478
Salary: £70000 - £80000
Job Status: Permanent / Full Time

Position Title:    Regulatory Affairs Snr. Manager

Reporting To:    Site Quality Director [direct reporting] + Qualified Persons [functional reporting]

Regional Level: EU Regulatory Affairs Senior Director [functional reporting]

Department:      Quality

Package:   £70-80K plus 18% bonus and £450 car allowance per month (relocation package also available)

               

1 Essential Goals:

  • 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

2 Role Dimensions:

  • Human: transverse role ramifying:

-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)

3 Key Responsibilities:

  • 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

5 Experience:

(A) ESSENTIALS:

  • Education: EU Life Science first degree, e.g. in Pharmacy, Chemistry, or Microbiology, etc.
  • Regulatory knowledge:

-UK, EU, US & ICH core pharmaceutical regulations

-English : technical writing + speaking

  • Job experience: 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
  • Diversity: national to international (customers’ contacts, network) / multidisciplinary
  • See SND Organisational Chart + EU RA network

(B) 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)

 

If you feel you’d be the right fit for the role, please click the apply now button.