Regulatory Affairs Specialist
hace 2 semanas
We're looking for a skilled Regulatory Affairs Specialist to join our team at Teva Pharmaceuticals. This is a unique opportunity to make a difference in the lives of millions by ensuring compliance with international regulatory requirements and driving business growth.
About UsTeva Pharmaceuticals is a global leader in generic medicines, with a presence in nearly 60 countries and a diverse workforce of nationalities and backgrounds. Our mission is to make good health more affordable and accessible, and we're always looking for new ways to continue making a difference.
The OpportunityAs a Regulatory Affairs Specialist, you will be responsible for leading and managing all regulatory activities associated with development, registration, and maintenance of Drug Master Files (DMFs) according to current international regulatory requirements. This role requires strong technical knowledge, attention to detail, and excellent communication skills.
Your Experience and Qualifications- High degree in relevant field, e.g. chemistry/biochemistry/biology or biotechnology.
- Conversational English and at least 5 years of experience in a similar role.
- Support the life cycle management of APIs from RA perspective.
- Review and approve ROS, specification, and analytical control when required.
- Coordinate DMF preparation and related activities for On Time Submissions for all relevant markets.
- Proactively collaborate with the Regulatory Specialist team members, which support the submission or answer service requests.
- Prepare a DMF specific high-level gap analysis report and proactively communicate any risk to the relevant departments.
- Follow up on the gaps' solving during the review period.
- Respond to deficiency letters and coordinate related activities.
- Coordinate pre-launch activities from RA perspective.
- Manage the regulatory aspects and related tasks of the assigned commercial APIs.
- Evaluate change requests and address the required submission per market to support the requested change.
- Follow through the submission.
- Maintain up-to-date the DMFs according to the required regulation of updating per market.
- Support customers regarding Service Requests, giving relevant professional information in the shortest time.
- Continue learning of regulatory guidance, SOPs, and work processes.
$90,000 - $120,000 per annum, depending on qualifications and experience.
Benefits- Ongoing training and professional development opportunities.
- A comprehensive benefits package, including medical, dental, and vision insurance.
- A 401(k) retirement plan with company match.
- Generous paid time off and holidays.
If you are a motivated and organized individual with a passion for regulatory affairs, please submit your application, including your resume and cover letter, via email to [insert email]. We look forward to hearing from you
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