Regulatory Senior Specialist

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:

• Develop and implement regulatory strategies for OTC pharmaceutical products to ensure timely approvals and compliance with regulatory requirements.

• Prepare review and submit regulatory documents including New Drug Application (NDAs) Abbreviated New Drug Applications (ANDAs) and Marketing Authorization Applications (MAAs).

• Ensure compliance with regional and global regulatory standards including FDA regulations EMA guidelines and other relevant authorities.

• Maintain accurate and up-to-date regulatory documentation and records. Prepare and submit annual reports and other regulatory filings.

• 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.

• In-depth understanding of regional and global regulatory requirements for OTC pharmaceuticals. Experience with FDA regulations EMA guidelines and other international regulatory standards.

• 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 4000 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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