Regulatory Executive

Company : Clinchoice

Job Type : Full Time

Remote / Work from Home

Number of Applicants

:

000+

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Job Description - Regulatory Executive

Regulatory Executive at ClinChoice (View all jobs)
Philippines 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 world.

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 counter-parts. Main Job Tasks and Responsibilities:

Develops and implements regulatory strategy for assigned product development candidates and/or marketed products.

Provides direction for assigned programs by coordinating all aspects of regulatory submissions and responses and regulatory management of products over their life-cycle

Represents Regulatory Affairs on internal project teams and provides advice to project teams and line departments on regulatory requirements, guidelines, and strategy

Works collaboratively with project team members and line departments to facilitate efficient submissions and rapid approvals of regulator applications

Works collaboratively with Regulatory Affairs colleagues to ensure integrated, wellcoordinated approaches to planning regulatory submissions and responses and developing solutions to regulatory issues.

Support client on the timely preparation and submission of INDs, NDAs, BLAs (and corresponding international registration cosmetic packages), amendments/supplements/variations to these applications, and responses to regulatory agency questions.

Develop and maintains draft and final labeling for assigned products, works with labelling team members to achieve consensus on appropriate content, updates, and responses to Regulatory Agency comments.

Accountable for supporting Client in regulatory strategy and regulatory development plans for assigned products, projects, and other initiatives.
Education and Experience:

Bachelor’s degree in science or above and in alignment with project / business team requirements

Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream
Our Benefits:

Daily Meal Subsidy

Flexible working hours

Work from home (at least 2x a week)

HMO coverage up to maximum of 2 dependents subsidy

15 SL and 15 VL

Monetized leave

Annual Salary Increase

Clothing Allowance

Rice Allowance

Laundry Allowance

Excellent work-life balance

Dedicated Line Manager

Full performance and development process with end of year reviews

Career opportunities within in ClinChoice, locally and globally

Employee satisfaction survey - your feedback is important for continuous improvement
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: #LI-KA1 CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated