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 Affairs Manager (OTC products) for 3 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 client counterparts.
Main Job Tasks and Responsibilities:
KEY RESPONSIBILITIES
1. Management of a product or specified products within a therapy area for OTC Medicines, Cosmetics, Medical Devices and/or Food Supplements.
2. Principal responsibilities will be within Consumer Health OTC medicines but may also include assisting in regulatory support for other product types such as Cosmetics, Medical Devices and Food Supplements.
3. Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
4. Supports the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
5. Supports the team with regulatory strategies (local and regional) in line with business plan.
6. Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
7. Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency questions and other correspondence in accordance with EU regulations and guidelines.
8. Sign off of packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions via the relevant internal systems.
9. Ensure Marketing Authorisations are maintained and renewed.
10. Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
11. Ensures compliance within the department by ensuring:
12. Global, Regional and local databases are fully maintained.
13. Processes, SOPs, working instructions and Job Aids are adhered to.
14. Update relevant local and global databases to track current product information.
15. Provides regulatory advice and performs due diligence for product acquisitions and distributor agreements with third parties (as appropriate).
Good Regulatory Practice
1. Maintain awareness/knowledge of current regulatory legislation.
2. Ensures regulatory best practice at all times.
3. Monitor changes in the regulatory environment and highlight any potential impact on the client products.
Customer Service
1. May act as an ambassador for the Regulatory Affairs department to raise profile of team both internally and externally.
2. May represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice (as appropriate).
3. Interactions with Regulatory Agency.
4. Seek advice when appropriate.
5. Respond to requests for further information and queries.
6. Resolve any regulatory matters and expedite approval of pending applications.
7. Provides regulatory guidance to internal stakeholders, to allow them to make key decisions on business-critical activities and project feasibility.
8. If required, represent the client and provide regulatory advice at e.g. joint Company/Trade Association initiatives, Regulatory Agency meetings etc (as appropriate).
Personal Development
1. Complete induction programme in line within the defined timelines.
2. Develop product and therapeutic area knowledge as needed.
3. Ensure that any processes or SOPs/working instructions/job aids roll outs are actioned in Compliance Wire and within the defined timeline.
4. Maintains training record (as appropriate).
SKILLS, KNOWLEDGE; QUALIFICATIONS & EXPERIENCE
1. Life sciences or chemistry graduate to honours level or equivalent with 8-10 years of work experience in Regulatory affairs in OTC products.
2. Works with minimal supervision to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
3. Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
4. May mentor Graduate and Regulatory Executive and provide day to day support (as appropriate).
5. Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial/strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc.
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: Regulatory Affairs, Reg Affairs, RA, Over the Counter, OTC, Consumer Health, MRP, Mutual Recognition Procedure, DP, Decentralized Procedure
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