Senior Regulatory Affairs Specialist Consultant - OTC products

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 Senior Regulatory Affairs Specialist Consultant (OTC products) with REMOTE option in DENMARK for 12 months contract to work with one of our Consumer Health partners, with a focus on over-the-counter (OTC) Pharmaceuticals. 

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.  

The Senior Regulatory Affairs Specialist has a thorough understanding of the regulatory environment in Denmark and other Nordic countries, including submission requirements, approval pathways, and compliance activities, with a focus on their impact on business objectives.

They ensure the success of product registrations, line extensions, and new claims in alignment with the business plan. The specialist manages the coordination, compilation, and submission of applications for medicinal products, medical devices, food supplements, and similar products to regulatory agencies. They also maintain compliance with local regulations and quality system requirements for all products.
Main focus is OTC medicinal products

Main Job Tasks and Responsibilities:

KEY RESPONSIBILITIES

Regulatory Strategy 
-    Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams
-    Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant.
-    Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non clinical data are consistent with the local regulatory requirements and support the proposed product classification and claims.
-    Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
-    Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority. 
-    Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level.

Regulatory Compliance 
-    Maintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross functional experts as appropriate and implements locally
-    Ensures that all products comply with local regulatory and quality system requirements.
-    Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions 
-    Reviews and approves promotional materials for assigned local Kenvue products and assists in claim support 
-    Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
-    Ensures that the enterprise Regulatory systems are accurate and fully maintained 
-    Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally
-    Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives 
-    Supports internal and external audits and inspections in collaboration with quality function

SKILLS, KNOWLEDGE; QUALIFICATIONS & EXPERIENCE

•    Relevant Bachelor's Degree or higher  
•    6+yrs related regulatory experience  
•    Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Medical Devices and Food Supplements.
•    Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions through the product lifecycle
•    Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
•    Full Proficiency in Danish and English 

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.

 

Keywords: Regulatory Affairs, Reg Affairs, RA, Over the Counter, OTC, Consumer Health, medicinal products

 

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