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Regulatory Affairs Manager

3 months ago

Uxbridge, United Kingdom Pharmiweb Full time
Position Overview:

Pharmiweb is in search of a Regulatory Affairs Manager to become a vital part of our Regulatory Intelligence Team.

Key Responsibilities:

The Regulatory Affairs Manager will engage in proactive global oversight and analysis of modifications in the regulatory environment, concentrating on the drug development continuum, from preclinical stages to market launch. This role will also involve the dissemination of pertinent regulatory intelligence to various stakeholders within Pharmiweb. Additionally, the Manager will prepare responses to cross-departmental inquiries and initiatives within the organization's Good Practice (GxP) framework. The individual will facilitate discussions across functions and coordinate feedback on industry draft policy documents available for public commentary. These tasks should be carried out independently, with occasional guidance from senior team members as necessary.

Regulatory Intelligence Monitoring:

The Manager will:
  • Continuously monitor the external regulatory landscape and intelligence sources related to drug and device development, including regulations, guidelines, and other relevant information from regulatory bodies, trade associations, working groups, and industry thought leaders.
  • Evaluate regulatory intelligence for its relevance and potential impact on internal processes, drug development initiatives, and regulatory strategies.
  • Identify critical business aspects of regulatory information and communicate effectively with internal and external stakeholders.
  • Regularly review incoming regulatory updates in the global intelligence database and share relevant information with appropriate functions within the organization.
  • Identify significant regulatory guidance documents open for industry comments.
  • Organize regulatory intelligence review meetings and learning sessions.
  • Assist in the compilation and distribution of regulatory intelligence newsletters within the organization.
  • Manage requests for intelligence queries from internal stakeholders, preparing and delivering responses that may vary in complexity.

Supporting Regulatory Policy Commenting:

The Manager may:
  • Assist in cross-functional discussions to assess the impact of new or revised regulatory policies and contribute to drafting comments for submission to industry organizations and health authorities.
  • Perform project management and administrative tasks, including managing timelines and documenting meeting minutes.

Regulatory Intelligence Systems and Processes:

The Manager will:
  • Input data into systems to facilitate effective management of operational intelligence data.
  • Collaborate on the development and enhancement of internal regulatory intelligence processes to improve efficiency.
  • Oversee the content and updates of the Regulatory Intelligence SharePoint and intranet resources.
  • Support cross-functional projects and initiatives aimed at continuous improvement.

Qualifications:

To be considered for this role, candidates should possess:
  • A minimum of a Bachelor's Degree; an advanced degree in life sciences or certification in Regulatory Affairs is preferred.
  • At least 5 years of experience in the biotech or pharmaceutical sector or with health authorities.
  • A solid understanding of the drug development and commercialization processes on a global scale.
  • Experience and knowledge in Pharmacovigilance.
  • Proficiency in additional areas such as CMC/Manufacturing, Clinical Development, Regulatory Affairs, Real-World Data, and Cell and Gene Therapy is advantageous.
  • Experience in interpreting regulatory guidelines and documents.
  • Proficiency in navigating regulatory intelligence databases.
  • Experience in sourcing regulatory requirements within the pharmaceutical industry.
  • Strong analytical skills to assess critical regulatory information and its implications.
  • Excellent organizational skills and the ability to work independently to meet deadlines.
  • A collaborative mindset with strong relationship-building skills across various organizational levels.
  • Attention to detail and a commitment to quality output.
  • Effective communication skills, both written and verbal, in a multidisciplinary team environment.

Company Culture:

Pharmiweb fosters an inclusive and diverse workplace that offers comprehensive benefits, including health and wellness programs, fitness initiatives, equity awards, annual bonuses, and paid time off for eligible employees.