Global Regulatory Affairs Job Description
Global regulatory affairs
provides regulatory support and leadership to the site ensuring compliance with global regulatory requirements & Abbott Quality System regulations.
Global Regulatory Affairs Duties & Responsibilities
To write an effective global regulatory affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included global regulatory affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Analyze safety sheets, national laws, treaties or any other regulations that includes, mentions or affects company’s products components
Maintain appropriate external contacts and negotiate with international health authorities (US, EU, and others) to obtain timely registration of the diagnostic products
Upload new or changed regulations, standards and guidelines in shared access locations such as SharePoint
Stay abreast of global IVD regulations and guidance, especially those relevant to Companion Diagnostics
Provides advanced administrative assistance to Vice President and members of Global Regulatory Affairs under general supervision
Prepares routine and non-routine correspondence, memoranda, reports
Manage and coach a small team of regulatory professionals
Regularly interact and strategize process improvement with the senior manager/director of Global Regulatory & Scientific Affairs
Establish and implement best practices related to labeling
Remove barriers for the team by resolving escalated regulatory issues and delivering difficult messages with confidence and conviction
Global Regulatory Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Global Regulatory Affairs
List any licenses or certifications required by the position: RAC, ISO, FDA, RAPS, 9001, IMA, APR, PMP, CMC, GRA
Education for Global Regulatory Affairs
Typically a job would require a certain level of education.
Employers hiring for the global regulatory affairs job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Pharmacy, Chemistry, Life Sciences, Biology, Education, Technical, Life Science, Engineering, Business
Skills for Global Regulatory Affairs
Desired skills for global regulatory affairs include:
Drug development process and regulatory requirements
Regulations
Drug development and regulatory policy
Excellent scientific and business judgment
New and emerging regulations and guidances
EU
Agency regulations and industry standards pertaining to regulatory
Regional and Global regulatory environment and how it impacts regulatory dossiers and registration
Canada
Laws
Desired experience for global regulatory affairs includes:
Review new initiatives, determine level of complexity and resource needs, and manage workload distribution for the team
Collaborate with key stakeholders throughout the organization and educate cross-functional leaders on the regulatory process, value, and purpose
Support partner development by establishing team and individual goals, leading performance reviews, and scheduling appropriate trainings
Recruit, interview, and train new partners
Provide technical leadership to the business by contributing guidance on technical issues related to label reviews, marketing material, ingredient statements, claims substantiation and communicating the information to technical and non-technical audiences
Leverage external network of industry experts, government agencies, academia, using strong technical expertise to resolve regulatory issues and provide insight into emerging science that will translate into potential business opportunities or reformulations
Global Regulatory Affairs Examples
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Global Regulatory Affairs Job Description
Job Description Example
Our growing company is looking to fill the role of global regulatory affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for global regulatory affairs
- Address and communicate escalated regulatory issues and collaborate cross-functionally with Research & Development, Category, Marketing, Quality Assurance, Creative, Commercialization, and Supply Chain to develop solutions that meet business objectives and ensure compliance
- Manage the coordination, compilation and worldwide submission of (new) Medical Devices (MD) and In-Vitro Diagnostics (IVD) to the regulatory agencies
- Supports licensing of products developed by Janssen Diagnostics
- Responsible for managing several multidisciplinary teams of professionals located mainly in US
- Develop the global regulatory strategy for the company’s medical devices and in-vitro diagnostic devices
- Prepare or coordinate the preparation of submission documents
- Make an impact assessment on company objectives
- Provides guidance and support to product development teams on regulatory issues
- Provide input on regulatory changes for the Quality System management review meetings
- Establish standard operational procedures to achieve efficiency within regulatory affairs
Qualifications for global regulatory affairs
- Bachelor’s degree in Food Science, Nutrition, International Business, or related field/experience
- Ability to lead and motivate others, particularly through times of change and ambiguity
- Ability to communicate effectively to team and key stakeholders and present technical information to non-technical partners in a clear and concise way
- Ability to represent the regulatory team’s point of view with confidence and conviction
- Ability to think strategically and set a vision for the team with clear goals and objectives
- Ability to provide feedback to direct reports, identify areas of opportunity, and establish development plans
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Global Regulatory Affairs Job Description
Job Description Example
Our company is searching for experienced candidates for the position of global regulatory affairs. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for global regulatory affairs
- Receive clients and marketers regulatory affairs requests regarding company chemical products
- Write reports and issue certificates according to the client’s need
- Help in writing guidelines and manuals for requests resolutions
- Collaborate with the team in the planning, development and implementation of projects
- Keeping a smooth communication process with the team and the business function
- Contribute to reach the KPI’s defined in the service level agreement
- Follow the internal procedures
- Comply with the company Policies and Values
- Provide expertise in regulatory affairs leading to the successful regulatory registrations and approvals/registrations/licenses of Pathology and Companion Diagnostic products in global markets
- With Regulatory Sr
Qualifications for global regulatory affairs
- Ability to build and leverage relationships throughout the organization
- Ability to work independently without close supervision on a daily basis
- Involvement in trade associations, working groups, and committees
- Familiarity with reformulation of food and beverage products
- A Bachelor's degree in Pharmacy, Chemistry, Biology or a related science/technical field is required
- An M.S., Pharm D or Ph.D
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Global Regulatory Affairs Job Description
Job Description Example
Our company is searching for experienced candidates for the position of global regulatory affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for global regulatory affairs
- Ensure the submission of high quality "Right first time" Module 3 Quality dossiers
- Manage change control process with focus on US FDA expectations
- Provide quality CMC input into Regulatory Development Plans ensuring consistency across programs for global project teams
- Responsible for FDA interactions as appropriate ,at request of HA, meetings, inspections, FAR/BPDR
- Establish proactive dialog and communication with FDA to facilitate timely feedback and foster optimal agency relations
- Ensure review and approval of global regulatory Module 3 documentation prior to FDA submission
- Define and implement regulatory strategies to ensure consistent regulatory standards and compliance across regulatory TAs for Module 3 quality submission
- Work closely with US QA/QC organization in regards to potential product quality issues, review and approval of FDA Field Alert Reports and possible product recalls
- Maintain knowledge of regulatory environment within the Quality regulatory area current and contribute to shaping future regulatory CMC environment
- Inspiring effective team dynamics that imparts a sense of commitment to business goals to the regulatory function
Qualifications for global regulatory affairs
- A minimum of 10 years of pharmaceutical industry experience is required, of which at least 5 years must have been in Regulatory Affairs-CMC
- Expertise in vaccine or large molecule early and late stage development is required
- The strongest candidates will have a solid understanding of biology, protein chemistry and direct regulatory experience with vaccines
- RAC or RAPS certification is preferred
- This position is located in Raritan, NJ or Titusville, NJ, and may require up to 25% travel, domestic and international
- Minimum of 8 years pharmaceutical industry experience and 5 years global regulatory experience
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Global Regulatory Affairs Job Description
Job Description Example
Our growing company is looking to fill the role of global regulatory affairs. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for global regulatory affairs
- Lead the development, communication, lifecycle management, and review of the CMC Regulatory Strategy Document for projects of increasing complexity
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment, and product withdrawal
- Manage execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems
- Is responsible for the efficient and effective, execution project management of post approval maintenance regulatory activities, to ensure successful delivery of assigned projects and activities within agreed timelines
- Utilises his/her understanding of stakeholders product expertise to deliver excellent regulatory support and maintain the base of our business healthy
- Drives, with the support of his/her line manager, his/her personal development to ensure outperformance
- Responsible for the Certificates and Samples (C&S) registration activities for a diverse portfolio of global drug products working with other functions across sites and departments
- Will represent Global Regulatory Affairs CMC C&S viewpoint and expertise on diverse teams, including risk assessments and mitigations associated with proposed strategies
- Develop and execute contingency plans for issues that affect registrations and continued lifecycle management of products
- Responsible for requesting certificates from Health Agencies, manufacturing sites and other affiliate offices and ensuring documents are correct and available in a timely manner
Qualifications for global regulatory affairs
- Development and preparation of successful regulatory strategies and ability to write a Regulatory Strategy Document
- Experience leading a project with development activities in at least two regions
- Demonstrated experience working in global organizations
- Strong awareness of current trends in regulatory affairs
- Ability to think & plan strategically
- Demonstrated experience leading teams to achieve successful Health Agency interactions
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Global Regulatory Affairs Job Description
Job Description Example
Our company is searching for experienced candidates for the position of global regulatory affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for global regulatory affairs
- Responsible to define the need for and to organize, request and track orders for registration samples, working with Regional and local regulatory affiliates and Global Supply Chain personnel
- Responsible to prepare, hold and lead cross-functional team meetings, take a leadership role on assigned projects and initiate & lead improvement projects
- Develop regulatory strategy for the company’s medical devices and in-vitro diagnostic devices and global strategy and expertise for diagnostics identified by Janssen Therapeutic areas
- May provide oversight for local operating company regulatory affairs staff
- Contributes to training of department staff members
- Will be required to influence work of other department members
- Acts as a "go to" person for nutrition and health claims for the CPW global business, supporting in the substantiation of CPW’s global brand communications and health claims
- Partners with the Innovation and the Cereal Bars teams to deliver impactful & credible communications through compelling claims and product improvements
- Leads on a given global regulatory issue(s) for the CPW business
- Builds networks with key internal stakeholders within CPW Globally and among the Partners to help deliver our Company Purpose
Qualifications for global regulatory affairs
- Experience speaking at external meetings and acting as a company representative on pharmaceutical industry committees is highly desirable
- Leadership, influencing & negotiation skills
- Support Global RA and REG CMC Teams in developing regulatory strategies for Development programs and Marketed Products
- Work closely with Quality, Manufacturing and Development functions to ensure a consistent regulatory approach to CMC issues
- Advice EMD Serono Technical Operations as to applicable FDA guidelines, necessary regulatory deliverable and change control assessmentto support successful right first time FDA approvals of manufacturing supplements
- Serve as the FDA reference with respect to CMC regulatory issues and as key FDA contact for CMC issues