[Remote] Regulatory Affairs Mgr at Thermo Fisher Scientific

India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job, at least 5 years
Proven project management experience, and experience performing effectively in a client facing role
Experience with EUCTR, scientific advice with EMA, EU local Health Authorities
Excellent English language (written and oral) communication skills as well as local language where applicable
Excellent attention to detail and quality as well as excellent editorial/proofreading skills
Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
Excellent negotiation skills
Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines
Excellent analytical skills

Responsibilities

Lead the preparation of global regulatory submissions and ensure high quality standards that meet local and regional requirements
Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity
Provide internal clients with up-to-date legislation and guidance as it becomes available
Ensure quality performance for key/managed projects
Manage project budgeting/forecasting functions
Identify and recognize out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications
Collaborate with business development in pricing and securing new business by making presentations to clients and developing proposal texts and budget in collaboration with other departments
Provide matrix/project leadership, training and guidance to junior team members
Ensure compliance with relevant organizational and regulatory SOPs and WPDs
Participate in launch meetings, review meetings and project team meetings
Coordinate global regulatory strategies on assigned (Phase 1 to 4) clinical trials, studies and projects and provide the technical/project leadership across regions
Support clients with strategic regulatory intelligence and guidance for the product development mainly during the clinical phases
Support and lead the preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements, also act as liaison with internal and external clients
Act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement
Arrange, lead, and report on client and regulatory agency meetings

Skills

Regulatory Affairs

Global Regulatory Submissions

ICH Guidelines

Clinical Trials

Regulatory Strategy

Project Management

Regulatory Intelligence

Client Liaison

Budgeting

Forecasting

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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