Director Regulatory Strategy (Cmc)

Director Regulatory Strategy (CMC)
at ClinChoice (View all jobs)
European Union
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Director of Regulatory Strategy (CMC) on a permanent basis. You will be working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.
As Director of Regulatory Strategy CMC, you will be responsible for leading and managing Regulatory Strategy engagements with our clients, providing strategic guidance and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review and execute tailored regulatory strategies that support our client's product development, registration, and post-approval activities.
Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!
Main Job Tasks and Responsibilities:

• Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.
• Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.
• Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance with clients' regulatory strategies.
• Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfaction.
• Conduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.
• Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.
• Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.
• Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.
• Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.
• Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.
• Participate in preparing written and presented bid developments for new clients.
• Prepare and present client metrics as needed.
• Identify opportunities for business growth to ensure ongoing client support and positive engagement.
• Provide input on business strategic plans and managing outcome.
• Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.
• Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.
• Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.
• Monitor the regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.
• Monitor the Regulatory environment and communicate any changes and impact assessments to all team members.

Education and Experience:

• Bachelor's or Master’s degree in a scientific field.
• Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.
• Small molecule or biologics experience.
• Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.
• Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.
• Strong understanding of drug development processes and regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.
• Leadership experience, including the ability to lead and mentor a team of regulatory professionals.

Specific Role Requirements and Skills:

• Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.
• Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.
• Proficiency in using regulatory systems, databases, and software.
• Established leadership and management skills with cross-functional teams in a matrixed organizational structure.
• Business and strategic orientation, development of people, and processes.
• Excellent oral and written communication skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.

The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry-average turnover rates. ClinChoice is an equal-opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
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