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Regulatory Affairs Manager
2 months ago
at ClinChoice (View all jobs)
Buckinghamshire, United Kingdom
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...
ClinChoice, is searching for an experienced Regulatory Senior Specialist to work with one of our Consumer Health partners, with a focus on over-the-counter (OTC) Pharmaceuticals. The Senior Specialist will be responsible for developing and supporting regulatory strategies for OTC drugs and ensuring compliance with regional and global regulatory requirements.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counterparts.
Main Job Tasks and Responsibilities:
Coordinate the submission of post approval activities for MRP/DCP products across EEA and coordinate worksharing (WS) procedures for CMC and non-CMC variation. Prepare and compile regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines. May represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice (as appropriate). Develop and implement regulatory strategies for OTC pharmaceutical products to ensure timely approvals and compliance with regulatory requirements. Support the EMEA Regulatory Affairs team with consolidated Calls for Information (CFI) and coordinate submission of PSUSA. Ensure compliance with regional and global regulatory standards, including FDA regulations, EMA guidelines and other relevant authorities. Work closely with Research and Development, manufacturing, quality assurance and marketing teams to provide regulatory guidance throughout the product development and lifecycle processes. Monitor and interpret regulatory developments, guidelines, and industry trends to inform internal teams and adjust regulatory strategies as needed. Provide training and support to internal teams on regulatory requirements and best practices.
Education, Experience and Skills:
University Degree in Pharmacy, Chemistry, Biology, or a related field. Advanced degree preferred. Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry, specifically with OTC drugs. Minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives. Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work effectively in a team environment. Exceptional attention to detail and organisational skills. Ability to manage multiple projects and deadlines in a fast-paced environment. Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
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 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.
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.
Key words: Senior Regulatory Specialist, Regulatory Affairs, Reg Affairs, RA, Over the Counter, OTC, Consumer Health, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated
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