Global Regulatory Writing Manager

Amgen Inc. (IR); Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amgen Inc. (IR) is seeking a Regulatory Writer to maintain relationships with cross-functional product teams and, under supervision, lead writing activities for regulatory submissions.

The role includes mentoring junior writers, coordinating with contract writers, and contributing to Global Regulatory plans and team goals. The ideal candidate holds a Doctorate or Master’s with multiple years of related experience, or a Bachelor’s with extensive experience, and has strong knowledge of ICH/GCP

Qualifications

• Doctorate or Master’s with 4–6 years of related experience.
• Bachelor’s with 6–8 years of related experience.
• Diploma with 10–12 years of related experience.
• Proficiency with word processing and MS Office platforms.

Responsibilities

• Author regulatory submission documents (e.g., Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols).
• Review and approve authored documents per SOPs.
• Lead or supervise regulatory writing activities for product submissions.
• Serve as functional area lead on product teams (e.g., Global Regulatory Team).
• Mentor junior medical writers and collaborate with contract writers as needed.
• Generate document timelines with team input and coordinate with cross-functional partners.
• Stay updated on regulatory guidance and SOPs.

Skills

Microsoft Office

Strong writing

Leadership in teams

Time management

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Diploma

Job description

Career Category Regulatory Job Description Career Category: Regulatory Job Description

Let’s do this. Let’s change the world.

In this vital role you will maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities.

Roles & Responsibilities

• Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents
• Conduct the formal review and approval of authored documents, following applicable standard operating procedures
• With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications
• Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
• May provide functional area input for Global Regulatory Plan and team goals
• May work with contract and freelance writers
• May participate in training and mentoring of junior medical writers
• May participate in departmental and cross-departmental initiatives, as appropriate.
• Generate document timelines, with team input
• Keep abreast of relevant professional information and technology

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications

• Doctorate degree OR Master’s degree and 4 to 6 years of directly related experience
• OR Bachelor’s degree and 6 to 8 years of directly related experience
• OR Diploma and 10 to 12 years of directly related experience

Preferred Qualifications

• Functional Skills: Proficiency with word processing and other Microsoft Office Programs
• Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds
• Ability to understand and follow complex standard operating procedures (SOP’s), guidance documents, and work instructions
• Understanding and application of principles, concepts, theories and standards of scientific/technical field
• Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance’s and requirements
• Soft Skills: Excellent written/oral communication skills and attention to detail
• Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment
• Proficient time and project management skills
• Self-starter with a drive and perseverance to achieve results

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen