• Job Description

  Req#: R0027245

  Job Description:

  Regulatory Affairs Manager

  At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.

  Our Technical Operations division develops, manufactures and supplies high-quality products so our patients can live better lives. Creating and delivering life-changing products means getting it right first time is a shared responsibility, so our global manufacturing teams work closely together to ensure quality, accuracy and safety at all times. That means a culture of empowerment, where speaking up is valued, and growth and development are constant.

  Ferring+You

  You will be responsible to ensure compliance with local regulatory, quality assurance and pharmacovigilance requirements of the Food and Drug Administration.

  You will be responsible to ensure accomplishment of Regulatory, Quality Assurance and Pharmacovigilance local requirements, preparation of registration files and scientific review of therapeutic area promotional material. Carry out of Regulatory submission processes and Pharmacovigilance case processing processes within agreed timelines.

  Your day at Ferring

  • Assigned as Regulatory Affairs (RA) person and responsible for the certificate process including regulatory submission processes.

  • Assigned as the Pharmacovigilance (PV) person and responsible for reporting of all types of ICSRs and daily mgmt. of cases and reporting of issues.

  • Assigned as Local Safety Officer (LSO) and responsible for monitoring the safety mailbox.

  • Assigned as the Department Document Responsible Person (DDRP) and responsible for updating guidelines and SOPs for Regulatory, PV and QA.

  • Coordination and compilation of documentation for clinical trial applications, new applications and renewals.

  • Coordination and facilitation of Change Requests (CR) including CR-mailbox ensuring distribution, reassignment and finalisation.

  • Liaison with external experts and Ferring M&S RAMs and interaction with production sites.

  • Assigned as the Local Complaint Coordinator (LCC) and the Local Recall Responsible Person (LRRP) and responsible for coordinating with relevant.

  • Assigned as the Quality Assurance (QA) person and responsible for the timely performance of the recall process including timely notification of a recall to the health authorities and feedback to Global Quality Assurance (GQA) in terms of advice obtained from the HA and actions taken by the Affiliate.

  Behind our innovation…There’s you

  • BS/Master in Pharmacy Life Science

  • Fluency in English

  • At least 5 years experience as RA Manager in Pharmaceutical or Medical Device Industry. Experience in PV/Regulatory area

  People come first at Ferring

  • Get inspired from our commitment to advocate for everyone’s right to build a family, no matter who you are, where you live or who you love

  • Our inclusive support package – “Building Families at Ferring” provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role

  • Parental leave for both birthing and non-birthing parents

  • Extended support on family building journey

  Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions. Imagine the power of your career when it’s Ferring + You.

  Behind our purpose… There’s you

  If our mission and your vision are aligned, please apply!

  We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.

  Location:

  Ferring Philippines

• About the company

  Ferring Pharmaceuticals is a Swiss multinational biopharmaceutical company specialising in areas such as reproductive health, maternal health, gastroenterology and urology.

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