Job Description
Are you passionate about navigating the complex world of international pharmaceutical regulations? Our company is seeking a dedicated Sr. Regulatory Affairs Specialist to join our Regulatory Affairs Department. If you're ready to make a global impact and drive compliance excellence, we want you on our team.
Job Description
Under the direction of the Regulatory Manager, the incumbent:
Manages regulatory activities for new products in order to get products to market according to company plans.
Handles timely submission and follow-up of post-approval labeling and CMC variations.
Develops drives and finalizes all applications for GMP/new product registrations in line with local regulatory requirements and with marketing plans.
Manages the renewal process in liaison with the HQs, ensuring that the renewal files are prepared, submitted and approved in due time.
Handles the control of packaging components artworks developed by labeling coordinator.
Updates and implements local regulatory procedures in a timely manner, in close synergy with the regional organization.
Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures.
Pro-actively shares intelligence on competitive products, generics/copies, as well as on emerging regulations.
Keeps abreast of trends and legislation, at both national and international levels.
Provides advice and recommendations to Management and to regional organization on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.
Requirements
Graduated from the Pharmacy, Chemistry, Chemical Engineering and Biology departments of universities,
At least 3 years of experience in the registration of medicinal products
Has good command of English,
Successful in human relations and open to communication,
Current Employees apply HERE
Current Contingent Workers apply HERE
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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