Regulatory Affairs Manager
Join Kindeva Drug Delivery to lead regulatory compliance and support the development and commercialization of new products worldwide.
Key Responsibilities
* 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.
Skills & Experience
* 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.
Key Capabilities
* 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.
What We Offer
* 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.
Additional Information
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.
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Legal
Industries
Pharmaceutical Manufacturing
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