Assistant Manager Regulatory Affairs (EU & UK)

• Conduct

  comprehensive CMC reviews

  of technical documentation for regulatory filings across the

  EU and UK markets

  .
• Perform

  Gap Analysis and Remediation

  for

  Module 3 (CMC)

  sections to ensure submission readiness and alignment with regulatory standards.
• Develop and implement

  regulatory strategies, processes, and timelines

  for the preparation and submission of

  Marketing Authorization (MA) applications

  .
• Prepare and compile

  new CTD dossiers

  ,

  variations

  , and

  renewals

  ensuring full compliance with applicable

  EMA/MHRA

  regulatory requirements and internal quality standards.
• Critically review documentation to ensure

  internal consistency

  , compliance with regulatory expectations, and support

  regulatory excellence

  .
• Collaborate with

  cross-functional teams

  including RD, QA, QC, Manufacturing, and external stakeholders for timely and accurate data collation and submissions.
• Ensure

  effective and efficient communication

  across teams to facilitate streamlined project execution and meet submission timelines.
• Maintain high-level knowledge of current

  country-specific regulations

  , keeping track of regulatory updates through respective health authority websites (e.g., EMA, MHRA).

Education Experience

• Master s degree in Pharmacy

  or equivalent qualification.

• 4 to 6 years of relevant experience

  in Regulatory Affairs, with a focus on EU and/or UK submissions.
• Equivalent combinations of education, training, and practical experience may also be considered.

Key Skills Competencies

• Strong technical skills in

  data analysis and interpretation

  of regulatory documentation.
• Excellent interpersonal and

  problem-solving

  skills with a proactive and solution-oriented approach.
• Effective

  negotiation

  and communication skills for liaising with internal teams and external agencies.
• Proficient in drafting and reviewing documents in line with

  global, regional, and national

  regulatory standards.
• Expertise in

  document management systems

  and tools like

  Excel, Outlook, PowerPoint, and Word

  .
• Strong

  presentation

  and reporting skills with the ability to explain complex regulatory concepts clearly.
• Demonstrated ability to

  analyze data systematically

  , apply regulatory logic, and compile well-organized submissions.
• Collaborative,

  results-driven

  , and self-motivated with the flexibility to adapt to shifting priorities.
• Capable of delivering

  high-quality outputs under pressure

  and within aggressive timelines.

Other Requirements

• Flexibility to work in

  cross-time-zone schedules

  , as needed to support global project coordination or agency interactions.