Director Regulatory Job Description
Director regulatory
provides regulatory CMC expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent.
Director Regulatory Duties & Responsibilities
To write an effective director regulatory job description, begin by listing detailed duties, responsibilities and expectations. We have included director regulatory job description templates that you can modify and use.
Sample responsibilities for this position include:
External quarterly and annual financial statements for US entities in accordance with FERC and state regulatory requirements, as appropriate
Lead other development functions for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD
Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to ensure conformance with regulations and existing regulatory approvals
Working with RQA ensure that BLL has a fully effective risk management framework (RMF) and ORSA in place that is fully embedded as part of the decision making process
Chair of the BLL ORSA Steering Committee
Deputy Chair of the BGL ICAAP Steering Committee and BGL Board ICAAP specific workshops
Subject matter expert in relation to the capital requirements and regulatory reporting requirements within the 16 countries / territories within EMEA
Support the EMEA Regulatory Controller with responses to consultation papers produced by various regulatory bodies
Support the EMEA Regulatory Controller with the review of regulatory returns submitted within the 16 countries / territories within EMEA
Support the Hong Kong and China Controller with keeping abreast of regulatory developments across the eight countries in APAC
Director Regulatory Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Director Regulatory
List any licenses or certifications required by the position: RAC, FEMA, CPA, RAPS, ASQ, CAMS, IV, TFD, ISO, FDA
Education for Director Regulatory
Typically a job would require a certain level of education.
Employers hiring for the director regulatory job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Engineering, Chemistry, Medical, Education, Business, Pharmacy, Biology, Life Sciences, Technical
Skills for Director Regulatory
Desired skills for director regulatory include:
Regulations
FDA
Regulatory requirements
CMC
Drug development process
Regulatory environment
EU
Operations
Guidelines
Clinical
Desired experience for director regulatory includes:
Respond to ad-hoc regulatory queries across EMEA and APAC
Deputise for the EMEA Regulatory Controller at the BGL Capital Committee and prepare and present papers when required to do so
Build relationships with Board Members and Non-Executive Directors and teams across the business
Actively search for improvements within the role
Ability to clearly and confidently communicate in verbal and written form with all levels of the business essential
Self-starter, quick learner, team player, with an ability to adjust to change and the desire to take on responsibility if required
Director Regulatory Examples
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Director Regulatory Job Description
Job Description Example
Our company is hiring for a director regulatory. 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 director regulatory
- Responsible for ensuring timely and accurate regulatory and management reporting pertaining to derivatives
- Leads and manages enterprise automation of derivative reporting
- Oversees preparation of timely and accurate derivative information required for capital calculations and reporting
- Responsible for the implementation of regulatory standards and pronouncements issued by OSFI relating to derivatives to ensure compliance
- Responsible to the ongoing operational effectiveness of systems for derivative transactions
- Advise and consult with business units on the operational aspects of reporting related to derivatives
- Work in tandem with the SOX testing team to ensure appropriate and effective processes and procedures are in place
- Actively coach/develop the technical and leadership skills of Managers and Assistant Managers
- Lead and manages enterprise automation of derivative reporting
- Oversee preparation of timely and accurate derivative information required for capital calculations and reporting
Qualifications for director regulatory
- Experience of understanding and responding to regulatory developments
- Knowledge of Solvency II preferred
- CA/ACA/ACCA/CIMA Qualified with a strong academic record preferred
- Organised and methodical, possessing attention to detail, ability to work under pressure within tight deadlines
- FERC (Federal Energy Regulatory Commission) exposure
- Minimum 8 years of general accounting/financial reporting experience
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Director Regulatory Job Description
Job Description Example
Our company is searching for experienced candidates for the position of director regulatory. 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 director regulatory
- Establish and promote a culture that empowers managers and staff to learn and apply leading auditing practices and principles, think outside the box, and continually strengthen individual and team capabilities
- Build relationships with key NGOs (non-governmental organizations) including, but not limited to, Alliance to Save Energy (ASE), Appliance Standards Awareness Project (ASAP),Alliance for Responsible Atmospheric Policy (ARAP), Natural Resources Defense Council (NRDC)
- Assist plan sponsors and staff with a variety of ERISA and technical retirement plan issues (not operational or systems related)
- Work with internal staff to stay abreast of industry developments
- Provide written analysis of legislative and regulatory developments
- Support the plan document design and production function
- Provide training support related to legislative/regulatory developments and plan compliance issues
- Create and standardize processes so that each implementation is easier than the last one
- Serve as the Global Regulatory Lead on project teams and key sub-teams
- Present Regulatory strategies and issues at team or governance meetings
Qualifications for director regulatory
- Strong analytical skills and working knowledge of FERC reporting and U.S. GAAP
- 10-15 years progressive financial industry and/or consulting experience
- Advanced written and verbal communication skills in English and preferrably EU languages (French, German, Italian and/or Spanish)
- Partner closely with the regulatory reporting, compliance & risk teams globally to support enterprise objectives and / or legal entity strategy
- Detailed technical knowledge and practical application of Basel III rules, specifically CRD IV is essential
- Good understanding of the balance sheet, capital instruments and capital reporting requirements
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Director Regulatory Job Description
Job Description Example
Our company is looking to fill the role of director regulatory. 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 director regulatory
- Lead the CMC regulatory activities for designated programs for small molecules and/or biologics in all global markets
- May act as a Project Manager for a large and complex stand-alone project or program, involving several regulatory or technical deliverables and/or region, and/or operations
- Must have experience in developing BLA submissions for complex biologic products
- Fosters organizational improvement and growth
- Creates and leverages partnerships for future success
- Leverages talent for organizational success
- Will work with Sr
- Mentors, leads, coaches and develops employees
- Defines standards for inspection management (preparation, conduct, follow-up and archiving), capturing and analyzing of inspection learnings in collaboration with other QM functions and Medicine Business functions
- US Regional lead within the Regulatory Sub-Team (RST)
Qualifications for director regulatory
- Knowledge of 403(b) and 457 plans preferred
- Superior knowledge of qualified plan design and administration
- Relevant retirement business experience
- You have a keen understanding of the FDA and similar regulatory bodies
- You are flexible, have a start-up mindset, and enjoy a fast-paced environment
- You have the ability to juggle multiple client interactions and deadlines simultaneously and the the versatility to collaborate with individuals at all levels and across various functions within regulatory and life sciences firms
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Director Regulatory Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of director regulatory. 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 director regulatory
- Help ensure compliant growth under applicable laws, regulations, guidelines, and company policies by strategically supporting the business and addressing problems/opportunities by generating alternatives to achieve desired outcomes
- Conduct regulatory promotional labeling and marketing compliance reviews in the R&D and commercial areas to help ensure that activities and communications are consistent with product labeling, are adequately supported and are in compliance with applicable laws, regulations and policies related to advertising & promotion of prescription products
- Develop and implement global strategies to facilitate the progress of Phase I through Phase III clinical development programs
- Provides support managing the company's compliance with law and FCC, state and other regulations
- Assist with the facilitation of company responses to regulatory authority invitations for public/industry comment on regulatory guidances and rules, in coordination with the Sr
- Management of the planning, preparation and submission of licensing applications (BLA/MAA)
- Manage and mentor direct reports and/or junior staff members
- Provides management oversight of staff
- Providing leadership to develop and implement regulatory strategies throughout the product lifecycle that are consistent with business unit goals and objectives
- Developing a highly functioning results-oriented business regulatory team
Qualifications for director regulatory
- Write regulatory documents to support regulatory agency submissions
- Establish relevant processes and procedures to support the Regulatory Affairs function activities
- Minimum of 10 years pharmaceutical industry experience with a minimum of 8 years in Regulatory Affairs
- Specific experience working on a successful NDA and MAA required, leading preparation of an NDA and MAA preferred
- Knowledge of global regulatory requirements desirable
- Knowledge of drug development Excellent written and oral communication skills
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Director Regulatory Job Description
Job Description Example
Our company is looking to fill the role of director regulatory. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director regulatory
- Ensures compliance to relevant policies, SOPs and Regulations
- May take leadership role in bid defense strategy and planning
- May lead/chair a session on Regulatory Affairs or related topics at a conference
- Provide direction and oversight of regulatory advertising & promotion compliance activities for assigned businesses
- Identify as early as possible, the required documentation and any content, quality and/or time-lineissues
- Is responsible for all regulatory interactions regarding a facility or project
- Communicates with state and federal regulators in meetings and by phone and letter
- Provides the necessary support to ensure that all technical concerns are addressed
- Coordinates directly with state and federal regulators
- Leads all licensing and permitting initiatives by providing oversight and by writing licenses and permits
Qualifications for director regulatory
- Early development experience of drugs and biologics a plus (CMC and pharm/tox/pk requirements)
- Bachelors AND/OR Master’s degree from an accredited institution in Medicine, Biology or relevant field
- Experience in GxP quality management systems
- Strategic thinking and ability for implementation
- Proficient knowledge in applicable regulations, company processes and procedures with ability to assess their impact
- Experience in interacting with Regulatory Authorities regulatory inspections