Regulatory Affairs Director Resume
Summary : As a Regulatory Affairs Director, provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned product(s) with a focus on translational areas.
Skills : Regulatory knowledge, Compliance and risk management.
Description :
- Provided intergovernmental relations advice to senior management relating to strategic objectives.
- Deployed industry best practices to lead MPI media relations efforts, in consultation with District media relations team.
- Created various communications materials including web, digital, print, and social media content.
- Coordinated District issues management work in relation to MPI.
- Monitored social media for community conversations and guided District messaging.
- Evaluated the effectiveness of communication campaigns and provided updates to senior management.
- Assisted in organizing meetings, receptions, and special events.
Experience
10+ Years
Level
Senior
Education
BSc in Life Sciences
Regulatory Affairs Director Resume
Summary : As a Regulatory Affairs Director, responsible for developing, aligning, and implementing regulatory strategies to ensure successful submissions and approvals with target labels for assigned biomarker-driven development projects on a global scale.
Skills : Project management, Communication.
Description :
- Ensured appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across assigned indications and compounds.
- Provided interpretation of regulatory agencies’ feedback, policies, and guidelines to internal colleagues.
- Kept up-to-date on current regulations and guidance; interpreted and notified appropriate colleagues and stakeholders as appropriate.
- Developed, reviewed, and maintained Regulatory and other company-wide and departmental policies and SOPs.
- Provided ongoing coaching for members of the crisis communications team, and coordinated related training including media relations training, ICS, and role-specific training.
- Developed and implemented regulatory strategies to support the clinical development of biomarkers and assays, ensuring alignment with organizational objectives.
- Worked closely within cross-functional teams, actively participating in decision-making processes related to biomarker and assay-driven drug development queries.
Experience
7-10 Years
Level
Management
Education
BSc in Chemistry
Regulatory Affairs Director Resume
Objective : As a Regulatory Affairs Director, drove opportunities for external engagement, contributing to relevant publications and participating in external speaking events to improve the company's visibility and influence in the regulatory landscape.
Skills : Problem-solving, Leadership.
Description :
- Served as the Regulatory Affairs representative on designated global project teams, offering strategic insights and mentorship on key development and regulatory documents.
- Coordinated the review process, ensuring scientific coherence and compliance with regional and global regulations.
- Engaged with major health authorities to optimize regulatory strategies and maintain positive relationships.
- Prioritized and led preparations for meetings and teleconferences with local and global health authority officials, focusing on biomarker and innovation-related topics.
- Kept abreast of relevant regulatory policies and guidelines, understanding their implications for clinical and scientific practices.
- Coordinated with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
- Provided regulatory support to other company functions during Regulatory Authority inspections.
Experience
2-5 Years
Level
Executive
Education
BEng
Regulatory Affairs Director Resume
Summary : As a Regulatory Affairs Director, responsible for collaborating with global regulatory science and cross-functional project teams on regulatory strategy development from clinical development to post-market activities.
Skills : Leadership, Negotiation.
Description :
- Served as Regulatory Affairs representative on facility/site Local Change Management Boards.
- Participated in assigned due diligence business activities and led the CMC review and recommendations.
- Reviewed and provided input on proposed health authority guidance documents on CMC issues.
- Oversaw and guided the preparation and maintenance of regulatory labeling for multiple products across the oncology therapeutic area.
- Provided strategic advice and guidance to cross-functional partners and stakeholders.
- Led and facilitated cross-functional labeling and related forums and meetings, such as CLWG, TPL, and USPI team meetings.
- Led or otherwise contributed to key system and process improvements.
Experience
7-10 Years
Level
Consultant
Education
BPharm
Regulatory Affairs Director Resume
Summary : As a Regulatory Affairs Director, supports the director of conduct and regulatory affairs in the delivery of timely and pragmatic support for regulatory engagement and interpretation of regulatory requirements relating to the PRA.
Skills : Attention to detail, Strategic thinking.
Description :
- Facilitated communication and reporting of performance metrics to stakeholders, ensuring transparency and promoting a culture of accountability.
- Continuously researched and stayed updated on industry trends, regulatory changes, and emerging best practices to inform strategic decision-making.
- Drove benchmarking initiatives to identify best practices and areas for improvement.
- Developed and implemented a comprehensive government relations strategy aligned with the business objectives of the cement company.
- Monitored and analyzed legislative and regulatory developments affecting the cement industry and provided timely insights to the executive team.
- Planned and managed the integration of multi-disciplinary regulatory programs into the project team development plans for all assigned projects.
- Coordinated internal discoveries and depositions with legal department staff.
Experience
10+ Years
Level
Senior
Education
BSc in Life Sciences
Regulatory Affairs Director Resume
Summary : As a Regulatory Affairs Director, responsible for leading the development and implementation of the global regulatory strategy for a project or a group of products of increasing complexity within the R&I portfolio.
Skills : Collaboration, Project management.
Description :
- Developed and maintained strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance.
- Integrated compliance considerations into risk assessment by partnering with Legal/Compliance colleagues.
- Provided advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising would be based.
- Provided input on process improvement and BMS guiding principles as needed.
- Engaged with colleagues within the department to help support them in their roles and development.
- Participated in trade associations to assist in deriving benefits from memberships, such as leveraging access to information and supporting advocacy efforts.
- Coordinated the development of and worked with others to provide regulatory training.
Experience
7-10 Years
Level
Management
Education
BSc in Life Sciences
Regulatory Affairs Director Resume
Summary : As a Regulatory Affairs Director, responsible for monitoring the development of new regulatory requirements or guidance documents and advising product teams of the impact on the business or development programs.
Skills : Regulatory compliance, Leadership.
Description :
- Reviewed and coordinated with state agencies for operational and compliance issues.
- Reviewed rules affecting implementation of projects being evaluated.
- Provided regulatory review of advertising and promotional labeling, disease awareness and training materials, new campaigns, and product launch strategies.
- Contributed to the organization’s strategic plan and annual plans, in areas such as quality and risk management, regarding registration matters.
- Monitored emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Wrote and periodically updated drug regulatory affairs (DRA)-related local SOPs.
- Reviewed draft registration files and submitted new and amended registration dossiers to obtain and maintain registration.
Experience
7-10 Years
Level
Consultant
Education
BSc in Life Sciences
Regulatory Affairs Director Resume
Summary : Over 5 years of experience in regulatory strategy, compliance, and submission management within the pharmaceutical and medical device industries.
Skills : Cross-Functional Team Leadership, Compliance and Risk Management.
Description :
- Developed and implemented global regulatory strategies for product approvals, ensuring alignment with business objectives and compliance with regulatory requirements.
- Led the preparation and submission of regulatory filings, including INDs, NDAs, BLAs, PMAs, and 510(k)s, achieving timely approvals from FDA, EMA, and other regulatory bodies.
- Managed interactions with regulatory agencies, responding to inquiries, providing clarifications, and negotiating favorable outcomes.
- Directed cross-functional teams in regulatory project planning, ensuring effective communication and collaboration across departments.
- Monitored changes in regulatory landscapes, provided strategic guidance to senior management, and advised on regulatory risks and opportunities.
- Oversaw the maintenance of regulatory compliance throughout the product lifecycle, including labeling, advertising, and post-market surveillance.
- Coordinated the development and submission of regulatory dossiers, ensuring accuracy, completeness, and adherence to timelines.
Experience
7-10 Years
Level
Consultant
Education
BSc in Life Sciences
Regulatory Affairs Director Resume
Summary : As a Regulatory Affairs Director, responsible for managing and enhancing relationships with government entities, regulatory bodies, and relevant stakeholders to ensure compliance with regulations and promote the interests of the company.
Skills : Data analysis, Contract negotiation.
Description :
- Provided input as required, for example on technical matters, for the investigational medicinal product dossier (IMPD).
- Ensured that quality standards were met, and all submissions met agreed deadlines.
- Maintained contacts and shared relevant information with stakeholders, internally and externally, including liaising with regulatory authorities.
- Prepared and participated in presentations on regulatory affairs matters, and provided advice to manufacturers and scientists.
- Directed the preparation and submission of regulatory agency applications, reports, or correspondence.
- Reviewed all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
- Provided regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
Experience
7-10 Years
Level
Consultant
Education
BSc in Life Sciences
Regulatory Affairs Director Resume
Summary : As a Regulatory Affairs Director, monitors and analyzes performance data to provide insights and recommendations for optimizing processes and enhancing overall performance and provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
Skills : Legislative knowledge, Legal writing, Regulatory submissions.
Description :
- Formulated or implemented regulatory affairs policies and procedures to ensure that regulatory compliance was maintained or enhanced.
- Communicated regulatory information to multiple departments and ensured that information was interpreted correctly.
- Managed activities such as audits, regulatory agency inspections, or product recalls.
- Developed regulatory strategies and implementation plans for the preparation and submission of new products.
- Provided responses to regulatory agencies regarding product information or issues.
- Maintained current knowledge of relevant regulations, including proposed and final rules.
- Investigated product complaints and prepared documentation and submissions to appropriate regulatory agencies as necessary.
Experience
7-10 Years
Level
Management
Education
BSc in Life Sciences
