Manager - Regulatory Affairs - Devices

3 weeks ago

Hyderabad, Telangana, India Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Regulatory Affairs Manager Devices

What you will do:

Lets do this. Lets change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans

- Lead and/or support JAPAC health agency engagements

- Lead and/or support JAPAC filing activities and associated health agency inquiries

- Support device design controls activities and documentation reviews

- Assess device-related standards and guidance for regulatory applicability; assist in establishing

- Amgen regulatory positions in the JAPAC region

- Perform change control regulatory assessments as it relates to JAPAC

- Develop and support implementation and maintenance of internal regulatory processes

- Perform device determination decisions for regulated items to be developed and/or used in JAPAC region

- Support supplier engagement teams and due diligence activities in the JAPAC region

- Review regulatory sections in development, quality, and supply agreements that impacts JAPAC region

- Support regulatory compliance initiatives in the JAPAC region

What we expect of you:

- We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications.

Basic Qualifications:

- Doctorate degree; or

- Masters degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or

- Bachelors degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience

Preferred Qualifications:

- Masters degree in regulatory affairs, engineering, or life sciences

- 6 or more years of experience in medical device regulatory affairs

- Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development

- Experience in drug delivery device or diagnostics device regulatory submission process

- Regulatory CMC specific knowledge and experience

- Mature project management and organizational skills

- Strong and effective oral and written communication skills

- Experience in Veeva Vault platforms

Note : For your candidature to be considered on this job, you need to apply necessarily on the company's redirected page of this job. Please make sure you apply on the redirected page as well.

(ref:iimjobs.com)

  • Manager - Regulatory Affairs - Devices

    3 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    Defying Imagination: A Regulatory Affairs Manager Devices RoleYou've earned your degree, now it's time to reach new heights. At Amgen, our mission is to serve patients, and we're driven by a shared sense of purpose.This role will challenge you to support the development and execution of regulatory strategies for drug delivery devices and combination...

  • Regulatory Affairs Manager

    2 days ago

    Hyderabad, Telangana, India beBee Careers Full time

    Medical Device Regulatory Compliance PositionThis is an exciting opportunity to join a dynamic team as a regulatory compliance officer responsible for ensuring our medical devices meet all applicable regulatory requirements and standards. The ideal candidate will have a strong background in regulatory affairs and experience in the medical device...

  • Regulatory Affairs Professional

    2 days ago

    Hyderabad, Telangana, India beBee Careers Full time

    We are seeking a highly skilled Regulatory Compliance Officer to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring our medical devices meet all applicable regulatory requirements and standards. This includes monitoring and interpreting evolving regulations, standards, and guidance relevant to medical...

  • Regulatory Affairs CMC Manager

    3 days ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time

    Job DescriptionLet's change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by:- Driving continuous improvement of processes and tools.-...

  • Regulatory Affairs

    1 day ago

    Hyderabad, Telangana, India Saraca Solutions Private Limited Full time

    Job DescriptionPrepare, review, file, and support premarket documents for global registrations for assigned projects.- Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.- Represent Regulatory Affairs as team member of product development projects from Concept through...

  • Regulatory Affairs CMC Manager

    4 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time

    Job DescriptionLet's do this. Let's change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by:Driving continuous improvement of processes and...

  • Regulatory Affairs CMC Manager

    3 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    Job DescriptionAt Amgen, our shared mission to serve patients living with serious illnesses drives all that we do.Weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Our focus is on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. We reach millions of patients each year.Our...

  • Regulatory Affairs Manager Medical Devices

    2 days ago

    Hyderabad, Telangana, India beBee Careers Full time

    Quality Management Systems LeaderWe need a seasoned professional to develop and lead our Quality Management System (QMS) aligning with global standards.The successful candidate will oversee the development and implementation of regulatory strategies, lead internal and external audits, and manage quality-related activities.Broad knowledge of quality...

  • Regulatory Affairs Professional

    19 hours ago

    Hyderabad, Telangana, India beBee Careers Full time

    Job Title: Regulatory Affairs ProfessionalAbout the Role:We are seeking a highly skilled Regulatory Affairs professional to join our team. As a Regulatory Affairs Manager, you will be responsible for developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout...

  • Medical Device Regulatory Specialist

    2 days ago

    Hyderabad, Telangana, India beBee Careers Full time

    Job SummaryWe are seeking a detail-oriented and knowledgeable professional to ensure medical devices meet all applicable regulatory requirements and standards. The ideal candidate will play a critical role in overseeing compliance activities, preparing regulatory submissions, and collaborating with cross-functional teams to maintain product and process...