Hikma Pharmaceuticals
Specialist, Regulatory Affairs
Hikma Pharmaceuticals, Oklahoma City, Oklahoma, United States,
Title: Specialist, Regulatory Affairs
Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people who are competent. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.Hikma intends to recruit a
Specialist, Regulatory Affairs
(m/f) to integrate
Regulatory Affairs New Submission
Department,
on-site work.Main Responsibilities:Handling of all pre-approval activities related to Marketing Authorization Applications (MAA) and Abbreviated New Drug Submissions (ANDSs), including reply to deficiency letters according to the regulatory guidelines.Handling of all post-approval activities related to Abbreviated New Drug Applications (ANDAs), Marketing Authorization Applications (MAA), Abbreviated New Drug Submissions (ANDSs), variations/supplements to current ANDA/MA/ANDS, Annual Reports and replying to deficiency letters according to the regulatory guidelines.Evaluate Change Controls, issue/update New Registered Product form (NRP's), prepare product information variations/labelling supplements, provide information for Annual Product Review (APRs), creation and revision of internal SOPs and DHFs whenever applicable.Support the site on the launch of new products, by performing all regulatory activities required.Prepare, review and implement labelling.Comply with the defined KPIs.Profile:Master’s degree in Pharmaceutical Sciences (Minimum).Experienced in EU Market (Preferred).4-6 years of professional experience.Responsibility, proactivity and teamwork.Maintains awareness of regulatory guidelines and updates.Organization and planning capabilities.Ability to work under pressure and to meet deadlines.Good analytical and negotiation skills.We offer:Direct contract with Hikma.Salary appropriate to the functions performed.Life insurance.Health insurance.Annual Performance Bonus.High career prospects.If you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day.
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Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people who are competent. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.Hikma intends to recruit a
Specialist, Regulatory Affairs
(m/f) to integrate
Regulatory Affairs New Submission
Department,
on-site work.Main Responsibilities:Handling of all pre-approval activities related to Marketing Authorization Applications (MAA) and Abbreviated New Drug Submissions (ANDSs), including reply to deficiency letters according to the regulatory guidelines.Handling of all post-approval activities related to Abbreviated New Drug Applications (ANDAs), Marketing Authorization Applications (MAA), Abbreviated New Drug Submissions (ANDSs), variations/supplements to current ANDA/MA/ANDS, Annual Reports and replying to deficiency letters according to the regulatory guidelines.Evaluate Change Controls, issue/update New Registered Product form (NRP's), prepare product information variations/labelling supplements, provide information for Annual Product Review (APRs), creation and revision of internal SOPs and DHFs whenever applicable.Support the site on the launch of new products, by performing all regulatory activities required.Prepare, review and implement labelling.Comply with the defined KPIs.Profile:Master’s degree in Pharmaceutical Sciences (Minimum).Experienced in EU Market (Preferred).4-6 years of professional experience.Responsibility, proactivity and teamwork.Maintains awareness of regulatory guidelines and updates.Organization and planning capabilities.Ability to work under pressure and to meet deadlines.Good analytical and negotiation skills.We offer:Direct contract with Hikma.Salary appropriate to the functions performed.Life insurance.Health insurance.Annual Performance Bonus.High career prospects.If you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day.
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