Amgen

Makes biotech medicines for serious illnesses

Senior Associate Regulatory Writing

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeHyderabad, Telangana, IndiaNo salary listedIn-person

About the Job

Requirements

Demonstrated ability to manage cross-functional stakeholders.
Communication and presentation skills.
Negotiation and conflict-resolution skills.
Strategic thinking and decision-making skills.
Ownership and accountability.
Ability to plan and execute timelines.
Ability to manage multiple deliverables simultaneously.
Ability to identify and mitigate risks.
Review coordination and comment-resolution skills.
Ability to work effectively with document management systems, Regulatory Information Management tools, SharePoint, and authoring platforms.

Responsibilities

Independently author routine to moderately complex documents, including Informed Consent Forms and amendments; Product Labeling and Packaging Specifications and amendments; sections of synoptic, abbreviated, and standard Clinical Study Reports, including pivotal reports with support; protocol amendments and country-specific protocol supplements; and minor or focused Investigator Brochure updates.
Manage document versions, reviewer comments, and approval flows end to end for assigned documents.
Ensure assigned documents are scientifically accurate, consistent across sections, and aligned with source data and program intent.
Prepare documents for quality control and inspection readiness in accordance with guidance documents and standard operating procedures.
Support audits or inspections by providing documentation history and rationale when needed.
Engage with Clinical, Safety, Regulatory, and Study teams to clarify inputs, resolve comments, and incorporate feedback efficiently.
Participate in document-related meetings as required.
Escalate risks, scope changes, or timeline pressures early to managers.
Track assigned deliverables and timelines.
Participate in internal trainings, knowledge-transfer sessions, and process improvements.
Deliver assigned work on time.

Career Category

Regulatory

Job Description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

Roles & Responsibilities

Independently author routine to moderately complex documents, including:
- ICFs and ICF amendments
- PLPS and Amendments
- Sections of CSRs (synoptic, abbreviated and standard; pivotal CSRs with support)
- Protocol Amendments and Country Specific Protocol Supplement
- IB updates (minor / focused updates)
Manage document versions, reviewer comments, and approval flows end to end for assigned documents.
Ensure assigned documents are scientifically accurate, consistent across sections and aligned with source data and program intent
Prepare documents to be QC and inspection ready, adhering to Guidance documents/SOPs
Support audits or inspections by providing documentation history and rationale when needed.
Engage with Clinical, Safety, Regulatory and Study teams to clarify inputs, resolve comments and incorporate feedback efficiently
Participate in document related meetings as required.
Escalate risks, scope changes, or timeline pressures early to Managers.
Track assigned deliverables and timelines.
Participate in internal trainings, KT sessions, and process improvements.
Consistent on time delivery

Collaboration Skills:

Cross-functional stakeholder management
Communication and presentation skills
Negotiation and conflict resolution
Strategic thinking and decision making
Ownership and accountability

. Project Management & Operational Skills

Timeline planning and execution
Managing multiple deliverables simultaneously
Risk identification and mitigation
Review coordination and comment resolution
Working effectively with document management systems, RIM tools, SharePoint, and authoring platforms

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size: 10,001+
Company stage: IPO
Headquarters: Thousand Oaks, CA
Founded: 1980

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