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Regulatory Affairs Manager
2 weeks ago
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 #J-18808-Ljbffr
