Regulatory Affairs Manager

Kindeva Drug Delivery Company; Loughborough; On-site; GBP 100,000 - 125,000; Full time

Job summary

A global healthcare manufacturer in Loughborough is seeking an experienced Regulatory Affairs Manager to oversee regulatory compliance for new product development and support strategic planning in regulatory changes. The ideal candidate will have over 10 years of relevant experience in the regulatory field and a degree in pharmacy or life sciences. The position comes with a competitive compensation package and various employee benefits.

Benefits

Attractive compensation package

Company pension scheme (up to 10% employer contribution)

25 days holiday per year (plus bank holidays)

Private Medical Insurance

Employee Assistance Program

Life assurance of four times life cover salary

Employee recognition program

Free on-site parking

Qualifications

• 10+ years relevant experience in regulatory or pharmaceutical industry.
• Additional regulatory qualifications are advantageous.
• Practical knowledge of the drug regulatory processes in EU/US.

Responsibilities

• Provide global regulatory input on New Product Development.
• Ensure regulatory oversight for marketing authorizations.
• Communicate regulatory learnings from other projects.

Skills

Excellent interpersonal and communication skills

Ability to work independently and in a team

Strong computer skills and organizational capabilities

Understanding of regulatory processes

Education

Degree in pharmacy or life science

Job description

Posted Sunday, October 5, 2025 at 11:00 PM

Our Work Matters:

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make:

We are seeking a detail orientated Regulatory Affairs Manager to support the growth of the Kindeva Business in the development and commercialization of new products for customers on a global basis.

You will play a crucial part in managing regulatory compliance activities for existing customer products, providing strategic planning for regulatory changes and regulatory advice on product development and maintenance issues.

Your expertise will contribute to maintaining our commitment to quality and safety in the marketplace.

Key Responsibilities include, but are not limited to:

• Providing global regulatory input on New Product Development and Marketed Product Support strategies including defining regulatory requirements with stakeholders as required.
• Ensuring effective regulatory oversight for assigned customer or Kindeva products and marketing authorizations.
• Advising stakeholders of the regulatory requirements associated with planned/unplanned changes.
• Managing regulatory authority meetings including preparing briefing documentation and presentations.
• Attending customer focused meetings, interfacing with identified client regulatory contacts.
• Participating in technical reviews of data in alignment with current global guidelines, ensuring data is generated to meet regulatory needs.
• Estimating regulatory resource needs for incorporation into project plan / monitoring of regulatory activities versus the project plan.
• Preparing submission project plans and agreeing the drafting, review and approval process and timeline for preparing regulatory submission documentation.
• Providing regulatory guidance to commercial launch teams and business development.
• Communicating regulatory learnings from other projects to the wider organization.

Skills & Experience:

• 10+ years relevant experience of European, US or Global registration procedures, or experience in other areas of the pharmaceutical industry.
• Degree educated in a pharmacy or a 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 (e.g. EU/US).
• Understanding of the drug development process from concept to launch including requirements for product development, manufacturing and marketing.
• Broad understanding of the pharmaceutical business, and of other relevant associated regulatory areas (e.g. Clinical Affairs, Medical Devices, Chemicals Regulations, etc.).

Key Capabilities:

• Excellent interpersonal and communication skills, both written & oral.
• Able to work both as part of a cross-functional team but also act independently.
• Enthusiastic and determined to achieve set objectives.
• Comfortable working with detailed technical information but also able to see the overall business picture.
• Possess strong computer skills and excellent organizational capabilities.
• Demonstrate flexibility, strategic thinking and drive to succeed.
• Deliver results accurately within demanding time frames.
• Handle a crisis situation in a professional and positive manner.
• Demonstrate a firm understanding of the overall role of the regulatory function within the wider business.
• Adapt to changing priorities, timelines, and regulatory expectations without compromising on quality.
• Maintain a high standard of accuracy, completeness, and documentation.
• Champion data integrity and a right first-time culture.

What we Offer:

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

Additional Information:

Location: Charnwood Campus, Loughborough

All applicants must be eligible to work in the UK.

We believe our people make the difference at Kindeva, we look for skilled, passionate, and driven professionals to come and work with us to help us excel in manufacturing technologies and processes, which bring lifesaving products to patients worldwide.

#LI-AC1

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Kindeva is an Equal Opportunity Employer