Regulatory Affairs Manager

Join Kindeva Drug Delivery to lead regulatory compliance and support the development and commercialization of new products worldwide.

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• Provide global regulatory input on New Product Development and Marketed Product Support strategies.
  
• Ensure effective regulatory oversight for assigned products and marketing authorizations.
  
• Advisory on regulatory requirements for planned/unplanned changes.
  
• Manage regulatory authority meetings, including briefing documentation and presentations.
  
• Attend client-focused meetings and interface with regulatory contacts.
  
• Participate in technical reviews of data aligned with global guidelines.
  
• Estimate regulatory resource needs for incorporation into project plan.
  
• Prepare submission project plans and draft, review, and approval process and timeline.
  
• Provide regulatory guidance to commercial launch teams and business development.
  
• Communicate regulatory learnings from other projects to the wider organization.
  

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• 10+ years relevant experience in European, US or Global registration procedures.
  
• Degree in pharmacy, life science or equivalent.
  
• Additional regulatory qualifications advantageous.
  
• Knowledge of the Global Regulatory Affairs environment – Guidelines and legislation.
  
• Practical knowledge of the drug regulatory processes in at least one major region (EU/US).
  
• Understanding of the drug development process from concept to launch.
  
• Broad understanding of the pharmaceutical business and associated regulatory areas.
  

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• Excellent interpersonal and communication skills, written & oral.
  
• Able to work as part of a cross-functional team and act independently.
  
• Enthusiastic and determined to achieve set objectives.
  
• Comfortable with detailed technical information and overall business picture.
  
• Strong computer skills and organizational capabilities.
  
• Demonstrate flexibility, strategic thinking and drive to succeed.
  
• Deliver results accurately within demanding time frames.
  
• Handle a crisis situation professionally and positively.
  
• Firm understanding of the regulatory function within the wider business.
  
• Adapt to changing priorities, timelines, and regulatory expectations.
  
• Maintain a high standard of accuracy, completeness and documentation.
  
• Champion data integrity and a right first-time culture.
  

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• Attractive compensation package.
  
• Company pension scheme (up to 10% employer contribution).
  
• 25 days holiday per year plus bank holidays and service days after 5 years.
  
• Private Medical Insurance.
  
• Company sick pay.
  
• Employee Assistance Program with 24/7 confidential helpline.
  
• Life assurance of four times life cover salary.
  
• Flexible working hours.
  
• Wellness programmes.
  
• Employee recognition program.
  
• Employee development.
  
• Free on-site parking.Discount and cashback at many retailers.
  
• Cycle to work scheme.
  
• Flu vaccinations.
  
• Employee referral scheme.
  

Working Hours: 37.5hrs per week

Location: Charnwood Campus, Loughborough

All applicants must be eligible to work in the UK.

Kindeva is an Equal Opportunity Employer.

Mid-Senior level

Full-time

Legal

Pharmaceutical Manufacturing