
Director Global Regulatory Writing
13 hours ago
It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
- Prepare and oversee the review and approval of scientific and regulatory submission documents.
- Serve as functional area lead on product teams.
- Maintain key business relationships with cross-functional product team members and appropriate management staff across the Amgen R&D organization.
- Provide expertise and guidance on document design and principles of good medical writing to individual staff, the department, product teams, and other functional areas.
- Supervise, train, coach, and mentor regulatory writers.
- Oversee the work of contract writers and CROs assigned to program documents.
- Manage and implement day-to-day departmental activities and operations, including hiring; resourcing projects; leading or participating in cross-functional process development, training, and oversight; business process ownership; and meeting management.
- Assist executive leadership with resource and budget planning and other department management activities, as needed.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Regulatory Writing professional we seek is a leader with these qualifications.
Required experience includes:
- Doctorate degree and 4 years of directly related experience OR
- Master's degree and 8 years of directly related experience OR
- Bachelor's degree and 10 years of directly related experience
The successful candidate will have the following skills:
- Experience reading, understanding, and applying regulations to a constantly changing environment.
- Proven leader in a team environment which requires motivation, negotiation, persuasion, collaboration, and analytical judgment.
- Expertise in analyzing scientific data and interpreting its significance in practical applications.
- Excellent written/oral communication skills and attention to detail.
- Superior time and project management skills.
- Self-starter demonstrating perseverance with a drive for results.
- Strong management and supervisory skills with previous experience developing and delegating to direct reports.
- Advanced knowledge of scientific writing and editing and a detailed knowledge of the clinical development process for new compounds.
- Advanced knowledge of related regulatory/industry considerations and guidelines, compliance issues, and/or issues affecting scientific discovery.
- Advanced understanding and application of principles, concepts, theories, and standards of the scientific/technical field.
- Recognized as a functional-area/subject-matter expert within a defined subject area.
- Applies expert knowledge and broad understanding of multiple disciplines to achieve efficiencies.
- Understands the core business process and purpose of the functional area in Amgen's commercialization process.
-
Global Regulatory Writing Manager
13 hours ago
Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionRoles & 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...
-
Strategic Regulatory Leader
5 hours ago
Hyderabad, Telangana, India beBeeRegulatoryDirector Full time US$ 1,37,520 - US$ 2,08,740Global Regulatory Writing DirectorThis is a leadership position that requires strong expertise in regulatory writing, scientific data analysis, and project management.Responsibilities:Oversee the review and approval of regulatory submission documents.Lead functional area teams and maintain key relationships with cross-functional team members.Provide guidance...
-
Global Regulatory Lead
5 hours ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000Job Overview:The position of Global Regulatory Writing Manager is a leadership role that oversees the development and submission of regulatory documents. This includes Clinical Study Reports, Investigator Brochures, and other critical documents.This key leader will guide a team of writers to ensure timely completion of high-quality documents. A strong...
-
Director of Regulatory Strategy
23 hours ago
Hyderabad, Telangana, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 25,00,000Job Summary:We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team. As a key member of our organization, you will be responsible for formulating and leading global regulatory strategies that drive innovation and maximize business benefits while ensuring regulatory compliance.The ideal candidate will have a deep...
-
Director of Regulatory Research
4 weeks ago
Hyderabad, Telangana, India Kamet Consulting Group Full timeJob Title: Director of Regulatory Research & IntelligenceLocation: Hybrid (Hyderabad)Industry: Life Sciences / Healthcare TechnologyExperience Level: 10+ yearsEmployment Type: Full-timeAbout the RoleKamet Consulting Group is seeking a high-impact Director to lead our Global Regulatory Research & Intelligence function while driving strategic business...
-
Urgent Search) Regulatory Writing Mgr
2 days ago
Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionIn this vital role, you will author and gain approval of scientific and regulatory submission documents that align with global regulatory standards. To 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)...
-
Director of Regulatory Research
1 week ago
Hyderabad, Telangana, India Kamet Consulting Group Full timeJob Title: Director of Regulatory Research & Intelligence Location: Hybrid (Hyderabad) Industry: Life Sciences / Healthcare Technology Experience Level: 10+ years Employment Type: Full-time About the Role Kamet Consulting Group is seeking a high-impact Director to lead our Global Regulatory Research & Intelligence function while driving strategic...
-
Director of Regulatory Research
2 weeks ago
Hyderabad, Telangana, India Kamet Consulting Group Full timeJob Title: Director of Regulatory Research & IntelligenceLocation: Hybrid (Hyderabad)Industry: Life Sciences / Healthcare TechnologyExperience Level: 10+ yearsEmployment Type: Full-timeAbout the RoleKamet Consulting Group is seeking a high-impact Director to lead our Global Regulatory Research & Intelligence function while driving strategic business...
-
Global Regulatory Affairs Specialist
3 weeks ago
Hyderabad, Telangana, India beBeeRegulatory Full timeJob Overview The International Program Regulatory Manager is a key role that supports the timely execution of registration plans for assigned portfolios in international countries. This position works under the supervision of the International Program Regulatory Director and partners with international regulatory teams and global line functions to drive...
-
Global Regulatory Expert
4 days ago
Hyderabad, Telangana, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000Regulatory Compliance SpecialistA key role that demands expertise in regulatory affairs and the ability to manage global CMC submission activities with strategic oversight.Key Responsibilities:Develop, implement, and maintain global CMC regulatory strategies that align with business objectives while ensuring compliance with regulatory requirements.Oversee...