- Collect and share with Corporate/ Campus on regulatory trends and developments in region/country of responsibility to actively anticipate any changes in the regulatory environment.
- Actively participate and influence direct regulatory industry association working groups to anticipate and influence changes which affect the approval of new products.
- Plan the submissions and other regulatory strategies according to local and corporate priorities
- Plan, execute and track locally and globally driven submission plans to achieve timely and compliant registrations for CEVAs products.
- Compile local submissions as needed.
- Manage the translation of submissions to local language and mock up review and packaging implementation according to local needs and regulations.
- Manage samples and reagents between the campus and the control authorities.
- Manage the response to LOQ in collaboration with corporate regional and technical experts and keep in touch with authorities in order to negotiate or reach the best result for Ceva.
- Execute activities and submissions for LCM activities in an area of responsibility and give the adequate support of local portfolio optimization/ management.
- Responsible to maintain a good track record of all submissions and national competent authority written/ verbal exchanges in collaboration with corporate to allow us follow up activities with full knowledge of past activities.
- Maintain an archive for documents and electronic files to maintain regulatory history of past activities
- Bachelor's or Master's degree in Pharmacy, Veterinary Medicine, Life Sciences, Chemistry, Biology, or related field
- Strong understanding of regulatory guidelines, compliance requirements, and industry standards.
- Knowledge of submission processes, dossier preparation, translations, and packaging requirements.
- Ability to interpret and anticipate regulatory trends and advise on strategic implications.
- Skilled in negotiation and communication with authorities to achieve favorable outcomes.
- Proficiency in document management systems and maintaining regulatory archives.
- Excellent project management skills to plan, execute, and track submissions globally and locally.
- Strong ability to lead teams, collaborate with executives, and present to stakeholders.
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Regulatory Affairs Manager - Jakarta Metropolitan Area - CEVA SANTE ANIMALE
3 hari yang lalu
Deskripsi
The success of a company depends on the passionate people we partner with.Together, let's share our talents.
As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.
We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.
Indeed, Our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.
As part of our "Diversity, Equity and Inclusion" policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.
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