Director, Regulatory Affairs Job Description
Director, regulatory affairs
provides regulatory expertise for new strategic areas and technologies as required for new product development including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements and regulatory compliance expectations during early development.
Director, Regulatory Affairs Duties & Responsibilities
To write an effective director, regulatory affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included director, regulatory affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Provides regulatory expertise for new strategic areas and technologies as required for new product development including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements and regulatory compliance expectations during early development
Partners with Policy to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's research and development programs to management
Develop and implement competitive and effective global regulatory strategies for 2 to 3 products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
Leads the Regulatory subteam, including regional project leads, RA CMC, and Regulatory Operations, to develop regulatory strategies for the project(s) at all development lifecycle stages
Serve as an influential and well respected spokesperson with staff at FDA, including leading meetings and preparations to facilitate expedited approval of original applications and supplements
Participate on multiple project teams represented by all functional areas of the company and act as the regulatory lead to ensure that activities are conducted in compliance with relevant laws, regulations, and guidance including with manufacturing, research, clinical, and quality assurance
Develop CMC regulatory strategy and manage regulatory activities and timelines for investigational and marketed products
Ensures that company policies, procedures and practices are in compliance with appropriate regulatory requirements
Deploy strategies, programs, policies, manuals, guidelines, and training programs to continually reduce risk of non-compliance with current and pending regional product regulatory guidelines, rules, and regulations
Provides advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes
Director, Regulatory Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Director, Regulatory Affairs
List any licenses or certifications required by the position: RAC, FEMA, RAPS, TFD, ASQ, CMC, US, CE, IV, QMS
Education for Director, Regulatory Affairs
Typically a job would require a certain level of education.
Employers hiring for the director, 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, Chemistry, Engineering, Education, Medical, Life Sciences, Pharmacy, Biology, Technical, Health
Skills for Director, Regulatory Affairs
Desired skills for director, regulatory affairs include:
Regulations
FDA
Regulatory requirements
CMC
Clinical
EU
Regulatory environment
Commercialization
Operations
Supplements
Desired experience for director, regulatory affairs includes:
Develop and manage the central regulatory team, ensuring a high level of regulatory expertise and resource which integrates with the global RD&A/regulatory organisation
Develop and lead a global regulatory organisation, both centrally & regionally
Expert observation, analysis and judgement
A minimum of 8-10 years of increasing documented success in biopharmaceutical field
Have strong strategic, analytical, problem-solving and critical thinking skills
Have outstanding written and verbal communication and presentation skills
Director, Regulatory Affairs Examples
1
Director, Regulatory Affairs Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of director, regulatory affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, regulatory affairs
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines and keeping management informed
- Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment, and regulatory precedent
- Prepare teams for and lead FDA (or other regulatory authority) meetings
- Manage and participate in the creation, review, assembly and submission of regulatory documentation including clinical trial and marketing applications and amendments to these regulatory files, as appropriate
- Support non-program specific projects as assigned such as department initiatives, business development assessments, clinical assessments and department training
- Coordinates submissions to FDA in support of proposed and ongoing development programs (e.g., new IND submissions, IND amendments)
- Ensure AIRM development products comply with regulatory requirements appropriate for each stage of development in both U.S. and globally
- Ensure submissions are done on time, complete and accurate in accordance with regulations and corporate goals
- Ensure proper management of multiple active INDs/CTAs in clinical trials
- Defines the strategic regulatory direction for innovation and portfolio development and global launch excellence for Wave 1 and Wave 2 Markets
Qualifications for director, regulatory affairs
- Prior experience with filing CMC sections of the marketing applications is a must
- Be able to effectively work with and influence senior Business Line and Control Function personnel across many business units and countries
- Demonstrate the ability to represent the Bank effectively in dealings with regulators
- Be able to envisage how existing and new technology could be leveraged or employed to enhance compliance processes
- Demonstrate the ability to get things done while ensuring that key stakeholders feel engaged and involved in the successful outcome
- Have strong leadership and interpersonal skills to provide leadership and direction when required, to work independently
2
Director, Regulatory Affairs Job Description
Job Description Example
Our innovative and growing company is hiring for a director, 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 director, regulatory affairs
- Manage all aspects of labeling and packaging activities to ensure labeling is compliant with the regulations and ready for product launch
- Assures timely regulatory clearances and approvals for product launches in all target markets and provides guidance to direct reports for the preparation and compilation of regulatory submissions for assigned projects consistent with established regulatory policies and priorities
- Responsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies
- Exercise highly complex level of independent judgment and execution directly impacting the operational results of the business unit
- Identify and assess external innovation opportunities connected to the area of responsibility– both screening & technical due diligence (or designate team member)
- Develop and execute regional regulatory public policy advocacy strategies with government agencies, trade associations, and non-governmental organizations
- Lead regional inputs to global product requirements database, and maintain forward-looking regulatory road-maps to inform product planning process
- Drive regional outcomes to support global regulatory affairs objectives and priorities
- Develop and maintain strong relationships with business functions, including government relations, marketing, engineering, manufacturing, and supply chain
- Develop and maintain strong working relationships with federal government agencies, including, but not limited to the U.S. Dept
Qualifications for director, regulatory affairs
- Be able to convey factual and conceptual information on complex regulatory issues that require detailed explanation and interpretation
- Experience in credit, market, liquidity or operational risk
- An LL.B, MBA, or C.A
- 7 to 10 years of progressive industry experience gained at a bank, regulator or SRO
- Minimum 10 years relevant / regulated industry experience is required
- PMA experience is preferred
3
Director, Regulatory Affairs Job Description
Job Description Example
Our company is growing rapidly and is hiring for a director, 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 director, regulatory affairs
- Manage timelines in cooperation with project management, operations, subject matter experts and Regulatory Operations to ensure on time regulatory submissions
- Assist in review of IOPS change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements
- Provide guidance on the processing of amendments to clinical trial CMC documentation
- Support establishing, managing and maintaining a knowledge base of current and emerging legislation and regulatory requirements and guidelines in the CMC field
- Assist in review of manufacturing change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements
- Participate, as needed, in planning, organizing and managing the CMC component of pre-IND, pre-BLA and other Type C meetings with the FDA
- Assist with the planning, scientific writing and perform critical reviews of ex-US agency documentation, including but not limited to IMPDs, MAAs, amendments, variations and agency briefing documents that are related to CMC
- Provide support to regulatory inspections, as needed, at the Raheen site or at other sites if the inspection relates to regulatory CMC issues
- Assist in tracking of CMC regulatory commitments for IMPDs, CTAs, and MAAs
- Participate, as needed, in planning, organizing and managing the CMC component of End-of-Phase 2 and pre-submission meetings with EMA and national competent authorities
Qualifications for director, regulatory affairs
- Senior leadership experience is required, including line management of multiple levels of reporting
- You have a degree from a top university
- You have a keen understanding of data, real-world evidence, and potential applications for clinical research and safety surveillance
- You are famailiar with oncology and the regulatory issues that are of particular interest in oncology (e.g., breakthough, EAP)
- You have a track record of success in developing long term relationships with regulatory agencies and life science partners in a strategic and abstract space
- You understand the common challenges faced by healthcare providers and life sciences firms and have experience bringing about mutually beneficial solutions
4
Director, Regulatory Affairs Job Description
Job Description Example
Our company is growing rapidly and is hiring for a director, regulatory affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, regulatory affairs
- Work with cross-functional teams to resolve emerging issues related to manufacturing operations with ex-US impact
- Manage timelines in cooperation with project management, SMEs and Regulatory Operations (Reg Ops) to ensure on-time regulatory submissions
- Assist in tracking of CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs
- Support IOPS by providing CMC related guidances so that their short-term and long-term goals are achieved on time and with highest quality
- Manages activities to compile and organize data and documentation for NDAs, BLAs, MAAs, INDs, CTAs, associated supplements, amendments, variations, annual reports/notifications, expedited safety reports, and certificates of pharmaceutical product
- Attends and manages activities related to FDA-Sponsor meetings
- Evaluates and communicates impact of regulations related to products and processes
- Trains and coaches regulatory staff on SOPs, regulations and guidelines
- Reviews advertising/promotional materials for prescription drugs and biologics to ensure compliance with regulatory requirements
- Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products
Qualifications for director, regulatory affairs
- Experience developing and implementing successful global regulatory strategies preferred
- Strong clinical foundation preferred
- Design well-informed global regulatory strategies
- Represent Regulatory Affairs on vadadustat project subteams and provide regulatory guidance (e.g., protocol reviews, report reviews, development plans)
- Assist in the preparation for regulatory agency meetings (e.g., Type C, Pre-NDA/MAA/NDS)
- Lead the coordination, preparation and timely submission of regulatory documents (e.g., INDs, MAAs, NDAs)
5
Director, Regulatory Affairs Job Description
Job Description Example
Our company is looking for a director, 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 director, regulatory affairs
- Manages FDA liaisons and is responsible for regulatory strategy, tactics and direction to product development in preparation of submission documents, responses to queries by regulatory agencies
- Review, compile, and submit variations, new applications, supplements and amendments and periodic reports, responses to Health Authorities as needed
- Ensure that all regulatory submissions are of the highest regulatory standards
- Provide support to the Raheen site during Pre-Approval Inspections
- Determines global regulatory and registration requirements as required
- Supervises the assembly and compilation of necessary internal and external documentation for U.S. and global dossiers and product registration
- Represents Regulatory Affairs in Product Development Team Meetings and Product Advancement Team Meetings
- Determines regulatory strategy associated with the development of new drugs and biologics regulatory strategy for post-approval changes to drugs and biologics
- Maintains surveillance of regulatory intelligence and communicates this information to project teams
- Undertakes risk analysis and manages the outcome as appropriate
Qualifications for director, regulatory affairs
- Strong leadership, interpersonal skills and the ability to work in a project team environment with Senior Management
- Proactive stance and initiative
- Fluency with Word, Excel, and Powerpoint is recommended
- Minimum of 10 years pharmaceutical industry experience and 8 years regulatory experience
- Experience in preparation and management of successful IND/BLA submissions in US
- Experience liaising with FDA and leading teams to achieve successful Health Agency interactions