Associate Director, Regulatory Affairs Job Description
Associate director, regulatory affairs
provides regulatory oversight for assigned projects, focused on non-clinical and clinical, and CMC aspects of drug development and associated regulations.
Associate Director, Regulatory Affairs Duties & Responsibilities
To write an effective associate director, regulatory affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included associate director, regulatory affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Leads US Labeling Working Group for new product labeling and works closely with the Global Labeling Team on alignment with the Core Data Sheet
Provide regulatory CMC guidance to the project teams to ensure development activities are compliant with relevant guidelines and governmental regulations
Leads efforts to create, modify, and review labeling documents, including prescribing information, patient labeling, and packaging/artwork content and device instructions for use with attention to competitive positioning
Support the organization and preparation of CMC regulatory submissions namely INDs/NDAs/BLAs and CTD applications including scientific and technical review for accuracy, soundness and regulatory appropriateness
Maintain CMC sections of IND/NDA/BLA dossiers including amendments, variations and annual reports with respect to compliance with regulatory submission timelines
Work closely with Technical Operations Team, Quality Assurance and relevant Contract Manufacturing Organizations at external vendor facilities
Ensure timely preparation and management of all necessary documentation for regulatory submissions to support the CMC sections of marketing applications and post-approval supplements based on information provided
Ensure that the content and format of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure, and
Assesses the regulatory requirements and activities for changes to existing cleared Medical Devices
This function supports the US Clinical Laboratory accreditation, licenses & permits for the CLIA laboratory in Huntington Valley, PA, and worldwide licensing of particular IVDs developed for Janssen Diagnostics
Associate Director, Regulatory Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Associate Director, Regulatory Affairs
List any licenses or certifications required by the position: RAC, RAPS, BS, BA, RAPSC, ASQ
Education for Associate Director, Regulatory Affairs
Typically a job would require a certain level of education.
Employers hiring for the associate 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, Pharmacy, Chemistry, Biology, Life Sciences, Engineering, Technical, Education, Life Science, Medical
Skills for Associate Director, Regulatory Affairs
Desired skills for associate director, regulatory affairs include:
Regulations
CMC
Regulatory requirements
Clinical
Commercialization
Drug development process
Operations
Clinical development
FDA
Labeling
Desired experience for associate director, regulatory affairs includes:
Provide knowledge on characterization and purification techniques for biologic products for recombinant proteins and their associated manufacturing processes
5 years experience in pharmaceutical/biologics regulatory, legal, scientific, medical, or marketing disciplines
Support ongoing and future RMAT (e.g., cell therapy, gene therapy, cellular immunotherapy) efforts
Responsible for North American Regulatory activities for cell and gene therapy compounds in development in the assigned RMAT portfolio
Execution of regulatory policy focused efforts, and participating in internal and external activities to shape the environment for RMAT
Will propose strategy for regional Health Authority interactions subject to endorsement by GRL and PDT
Associate Director, Regulatory Affairs Examples
1
Associate Director, Regulatory Affairs Job Description
Job Description Example
Our growing company is looking for an associate 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 associate director, regulatory affairs
- Coordinates submissions to FDA in support of proposed and ongoing development programs, , new IND submissions, IND amendments
- Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment
- Engages with key stakeholders and teams in the creation and execution of FDA compliant programs for product sampling, speaker events, medical congresses, launches, market research and competitive analysis
- Serves as the primary point of contact with the FDA Office of Prescription Drug Promotion on all matters including subpart H clearance
- Provides upon request analysis of competitor labeling in the relevant therapeutic area
- Responsible for continuous quality and compliance throughout the packaging labeling process
- Responsible for CMC filings supporting the progress of investigational product in Phase I through NDA for drugs, biologics and devices
- Responsible for the timely completion of well-organized, scientifically sound regulatory CMC submissions, to include DMFs, INDs, CTXs, NDAs, BLAs, IDEs, PMAs, and required amendments
- Contributes to writing expert summaries of CMC submissions
- Maintains an advanced level of understanding and awareness of existing and forth coming legislation and guidelines related to CMC
Qualifications for associate director, regulatory affairs
- B.S / M.S / Pharm
- Demonstrate ability to navigate in an evolving environment
- Demonstrate ability to work in conjunction with regional and functional (e.g., combination/device) leads in a global setting
- Propose strategy for US Regulatory commenting efforts for RMAT
- Manages the coordination, compilation and worldwide submission of (new) Medical Devices (MD) and In-Vitro Diagnostics (IVD) to the regulatory agencies
- Specifically for Companion Diagnostics, bridges requirements between Drug and IVD regulatory affairs and development teams
2
Associate Director, Regulatory Affairs Job Description
Job Description Example
Our growing company is looking for an associate director, regulatory affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate director, regulatory affairs
- Participates in or leads CMC meetings with regulatory agencies
- Prepare and coordinate accurate and timely submissions to health authorities (HA), in particular FDA, including strategies to address HA requests and responses for the assigned medical device or device aspect of combination products
- Act as liaison between company and FDA and other health authorities for assigned programs
- Perform/manage critical analyses of data (clinical, preclinical and manufacturing), independently develop interpretations and conclusions
- Assist with the scientific writing and review of a BLA and evaluate conformance with the regulatory requirements
- Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs
- Liaison responsible for communication with FDA and other health authorities for assigned programs
- Continually monitor newJy published FDA guidelines and international guidance documents in the context of new and ongoing development programs
- Contributes to the development and realization of business, by development of adequate regulatory strategies
- Responsible for managing several multidisciplinary teams of professionals located mainly in Europe and US
Qualifications for associate director, regulatory affairs
- Maintain appropriate external contacts and negotiate with international health authorities (US, EU, a.o.) to obtain timely registration of the diagnostic products
- Establish standard operational procedures to achieve efficiency within regulatory affairs, including the interfacing with other departments across MD&D, IVD and Drug development
- Identify educational needs, set up training sessions, and provide information on applicable regulatory topics to involved personnel across applicable legal entities
- Provide input to the management team in establishing short and long term business strategic plans and objectives
- Minimum is a Bachelor’s Degree is required
- Minimum 8 years of overall experience is required
3
Associate Director, Regulatory Affairs Job Description
Job Description Example
Our company is searching for experienced candidates for the position of associate 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 associate director, regulatory affairs
- Responsible for design and implementation of EMEA best practices for the development of new labeling review and approval procedures and evaluation of existing procedures for practical application
- Accountable for the interaction between the group and Global Labelling, ensuring appropriate EMEA input into global processes, CCDS changes and global understanding of EMEA procedures and regulations
- May have responsibility for the development, maintenance and global implementation of company core labeling for mature product(s)
- Will be accountable to Global labeling for global responsibilities
- Prepares and executes aspects of US regulatory affairs, and ensures integration into global regulatory strategy
- Ensures exemplary behavior, ethics and transparency within the company and with regulatory agencies
- Lead the Regulatory Sub-Team (RST)
- Provides regulatory direction in the development and approval of compliant advertising and promotional materials, disease state education, field training materials, and external communications
- Maintains a thorough understanding of OPDP requirements keen awareness of enforcement trends and is confident in their analysis and application to compliance assessments
- Prepares presentations and trains other departments and outside speakers
Qualifications for associate director, regulatory affairs
- RAC or RAPSC certification is preferred
- This position is located in Raritan, NJ or Titusville, NJ and may require up to 20% travel
- Ability to provide strategic and operational guidance across all levels of the company and external vendors
- Advanced Degree or country equivalent, in life sciences preferred
- A minimum of a Bachelor’s Degree in Life Science or related discipline is required
- A minimum of 10 years experience working in the device, pharmaceutical or OTC environment is required
4
Associate Director, Regulatory Affairs Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of associate director, regulatory affairs. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for associate director, regulatory affairs
- Support the Head of Global Labeling in providing development and guidance to Labeling Managers and Senior Labeling Managers
- Maintain controlled records for historical, current, and ending labeling changes, and communicate labeling changes to stakeholders at the time of implementation
- Provide project management to the Labeling Team throughout the entire process, from the decision to update a CCDS/USPI/SPC through notification to stakeholders, to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements
- When developing new labels, research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities
- This is a billable role, therefore expertise to conduct billable project work is also required, preferably in the CMC/Biologics area
- Manage quality control over entire labeling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution
- Under the direction of the Head of Global Labeling, assist in implementing process improvements to increase the efficiency and effectiveness of the label review process
- Lead the development of CCDS, package inserts and equivalents and their associated Patient Labeling Documents
- Works collaboratively with colleagues in the Regulatory Affairs, Medical, Legal, and Commercial team members during promotional and scientific medical reviews
- Member on project teams and regulatory sub-teams, as appropriate
Qualifications for associate director, regulatory affairs
- Minimum of 10 years of industry experience with at least 6 years of Regulatory CMC experience
- At least 10-12 years in pharmaceutical industry regulatory affairs
- Strong knowledge of drug development and regulatory policy
- Experience in preparation and management of successful NDA/BLA/MAA submissions in US
- Experience leading teams to achieve successful Health Agency interactions
- Experience with the clinical trial phase of development, IND/CTA requirements
5
Associate Director, Regulatory Affairs Job Description
Job Description Example
Our innovative and growing company is hiring for an associate director, 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 associate director, regulatory affairs
- Interpret for the Regulatory Affairs department and other departments, as appropriate, the impact of new FDA guidelines, policies, regulations, and conduct training, as needed
- Provide training in FDA regulations for advertising and promotion to internal employees
- Ensure regulatory compliance with all applicable laws, regulations and regulatory guidelines governing promotional programs and scientific interactions with healthcare professionals, payers, advocacy and other business partners
- Prepares SOPs, work instructions and provides related training presentations and Q&A sessions
- Participate in the Regulatory Sub-Team (RST) associated with the project
- Coordinate with RST members representing the Regions to develop a global regulatory strategy that is consistent enough to meet Health Authority expectations in all key target markets
- Align with the RST member from Global Regulatory & Scientific Policy over the external regulatory competitive environment to adapt product regulatory strategy accordingly
- Help establish key submission timelines (e.g., NDA/MAA), in consultation with RST members
- Partner with Submissions Project Management
- Participate in the development of the structure for high-level dossier content (i.e., Submission Content Plan (SCP)) and Submission Strategy Synopsis in conjunction with the SPM to meet Health Authority requirements and to incorporate company product and development plans
Qualifications for associate director, regulatory affairs
- Knowledge of global regulations for Medical Devices or In Vitro Diagnostics is required
- General knowledge of regulations for Drugs is required
- Experience in preparation and management of successful NDA/BLA/MAA submissions in US and/or EU
- Development and preparation of successful regulatory strategies
- Industry experience leading a project with development activities in at least two regions
- Experience as a scientific advisor to regulatory professionals as a RST Lead