Associate, Regulatory Job Description
Associate, regulatory
provides regulatory guidance and communicate regulatory requirements for drug products to internal teams and customers to ensure all development activities are in compliance with applicable regulations and guidelines.
Associate, Regulatory Duties & Responsibilities
To write an effective associate, regulatory job description, begin by listing detailed duties, responsibilities and expectations. We have included associate, regulatory job description templates that you can modify and use.
Sample responsibilities for this position include:
Effectively representing the Regulatory Controllers teams in ensuring compliance with US Basel III rules and instituting strong control practices and processes
Perform administrative functions as directed by Management to support projects and to ensure the smooth operation of the department
Maintain the regulatory databases up to date and as per the set criteria
Prepare and review Regulatory filings required by domestic and international regulatory agencies
Ensure accuracy and consistency of responses across multiple regulatory filings
Respond to regulatory inquiries related to prior period reporting
Work closely with the Compliance team to research new regulatory requirements and develop methodology and processes for ongoing reporting
Present updates and changes in regulatory reporting requirements to Executive Management
Liaise with internal and external technology teams to enhance workflow efficiencies and automation for regulatory reporting
Work directly with internal groups to support regulatory reporting responsibilities
Associate, Regulatory Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Associate, Regulatory
List any licenses or certifications required by the position: RAC, TSE/BSE, RS, RAPS, CCBCO, CRCM, CFA, ACRP, CIP, WIPP
Education for Associate, Regulatory
Typically a job would require a certain level of education.
Employers hiring for the associate, 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, Chemistry, Pharmacy, Engineering, Technical, Life Sciences, Biology, Education, Communication, Medical
Skills for Associate, Regulatory
Desired skills for associate, regulatory include:
Drug development
AZ Business and processes
Drug development process
Hazard Communication regulations and guidelines
Federal laws
Rules
Industry practices
Regulations associated with this consumer regulatory compliance practice
SDS regulations and requirements for Asia-Pacific countries
Regulations
Desired experience for associate, regulatory includes:
Report fund economics to Management Company for use in public filings
Prepare regulatory filings, including FR Y9C, Call Report, and other reports
Execute data quality reviews with business unit teams
Ensure compliance with and completeness of policies and procedures, including Sarbanes Oxley documentation requirements
5+ years of experience in the Legal and/or Securities industry
Ability to work independently within a team and across the organization
Associate, Regulatory Examples
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Associate, Regulatory Job Description
Job Description Example
Our company is hiring for an associate, 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 associate, regulatory
- Data Enslavement and distribution & relevant rules
- Assisting in the communication of new regulatory developments through appropriate media to relevant stakeholders throughout the firm
- Generating periodic and ad hoc reports on the status of regulatory developments and their impact on the firm
- Maintaining policies and procedures and facilitating their periodic review
- Ad hoc support to Regulatory Engagement & Development team
- Monitors compliance in regards to FAA/FCC guidelines for RF Exposure Safety and National Environmental Protection Act (NEPA)
- Monitors and tracks progress on all open compliance transactions
- Receive, track, and distribute IND Safety Reports to the Principal Investigator for acknowledgement of review and file
- Inform clinical operations of new study approvals including at initiation, amendments, and consent forms upon receipt
- Assist in SOP development, review and initiation
Qualifications for associate, regulatory
- Strong knowledge regulatory reporting software systems implementation
- 5 to 8 years working experience of Financial Regulatory Reporting in Banks
- Good understanding on Banking products and operation
- Problem solving and willing to learn
- Ability to understand complex multi-faceted problems, focussing on critical issues
- Ability to problem solve and trouble shoot with colleagues and third parties
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Associate, Regulatory Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of associate, regulatory. 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, regulatory
- Assist in conducting IACUC-sponsored activities such as facility inspections and protocol review to comply with regulations, policies, and nationally accepted standards, and to ensure that conditions are conducive to humane, responsible, and scientifically sound animal care and use
- Attend regulatory meetings and conferences
- Provide regulatory affairs consultative support, and develop skill set
- Assist in the writing, review, and preparation of eCTD compliant submissions and regulatory filings related to Rx and OTC drugs (including biologics), cosmetics,medical devices, Natural Health Products and veterinary drugs, and associated amendments/supplements to Health Canada, EU, US, and other regulatory Agencies
- Be responsible to provide input for various regulatory affairs projects, within specified time frames, ensuring accurate content, and quality control of each project
- Participate in meetings and strategic discussions with clients and teams
- Work with the team to ensure marketing materials for a client (or group of clients) follow the protocol established by pharmaceutical company clients for regulatory review
- Work with new internal client teams to establish appropriate procedures to meet the external client's regulatory review procedures and meet agency quality standards
- Advise internal client teams on submission strategy and requirements to minimize review period and ensure external client(s) satisfaction
- Prepare completed editorial content to Medical-Legal-Regulatory (MLR) review board
Qualifications for associate, regulatory
- Familiarity with risk management principles and philosophies
- Able to prioritize tasks and work well under pressure
- Well developed knowledge of trading practices and associated regulatory requirements
- Working knowledge of industry standard trading technologies
- Minimum 3+ years experience in equity compliance issues gained at an investment dealer, regulator or marketplace
- Good knowledge of MS Office (especially Excel/VBA), Bloomberg
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Associate, Regulatory Job Description
Job Description Example
Our company is hiring for an associate, regulatory. 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, regulatory
- Follow up audit recommendations and accelerating their resolution if the processes being improved are within the scope of open audit points
- Maintain effective internal working relationships with peers in the various Operations teams and beyond
- Obtain and challenge process changes in order to ensure on-time delivery of high-quality service with a view to exceeding client expectations
- Develop and maintain a strong client-centric approach required to build credibility and trust
- Deliver ad-hoc or additional tasks assigned during the course of work
- Review, analyze and resolve intermediate transactional data conflicts ensuring that data is accurate
- Promptly coordinate and complete routine data change requests
- Organizes workflow and Produces database summaries, statistics and reports/data extracts as requested
- Perform ad-hoc data investigations when necessary to profile and analysis data to address inquiries around data quality and integrity
- Support development of business processes to drive efficiency and accuracy
Qualifications for associate, regulatory
- Learn to write and edit technical documents
- The ideal candidate will have experience in Regulatory Affairs for the regional markets, with a focus on Regulatory CMC requirements for small molecule/biologic products, development, manufacturing and/or quality assurance
- Must have a proven ability to communicate effectively in both a written and verbal format
- Bachelor degree in life sciences/pharmacy with 2-4 years of experience in Regulatory Affairs
- Experience in Databases and experience in tracking / meeting deadlines
- Hands on experience of regulatory database management for eDMS/firstdoc, documentum
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Associate, Regulatory Job Description
Job Description Example
Our growing company is hiring for an associate, regulatory. 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, regulatory
- Keep abreast of related laws, regulations and official guidance
- Maintain knowledge and awareness of regulations and guidelines pertaining to drugs and biologics
- Act as the single point of contact (SPOC) for designated customers with the responsibility to focus on project management and building customer relationships
- Visit and/or host customer visits to develop opportunities
- Participate as adjunct business development team member
- Have a background in global chemical control regimes (REACH, TSCA/LCSA, Asia-Pacific equivalents) and in particular, chemical notification practices and associated IT systems
- Have relevant experience in chemical product regulatory compliance and product safety assessments, gained in the chemical, metal and pharmaceutical industry or an equivalent background
- Have knowledge and proficiency in chemical hazard communication systems
- You are adaptable and have a keen interest in working in a dynamic (VUCA) landscape with strong organisational skills
- You are known for your relationship building skills with a proven ability to engage and communicate effectively with customers, colleagues and managers alike
Qualifications for associate, regulatory
- Client focused approach to work and ensure client expectations are managed and met
- Experience in resource and timeline management for complex regulatory submissions
- General computer proficiency including Microsoft WORD, Excel, Access, Internet and experience with document tracking tools
- Perform gap analysis between requirements to meet the regulation and processes currently in place, identification of remediation requirements and closure to any data gaps
- Create and manage control reports to ensure quality of data remains at a good level
- Bachelor's Degree preferred but not required (Biomedical Engineering Degree would be a plus)
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Associate, Regulatory Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of associate, regulatory. 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, regulatory
- Review DOH and CMS plan contracts, and edit plan documents in compliance with contract requirements
- Draft policies, procedures and manuals
- Assist SVP in regulatory compliance and legal research
- Share knowledge of Regulatory Agency organizations
- Contribute to the preparation of submissions to Health Authorities by reviewing / summarizing scientific / research documents
- Assist in the coordination, collection and organization of information required by Regulatory Authorities
- Assist in client meetings and proactively liaise with clients on Regulatory Submission issues
- Monitor compliance with regulatory requirements in relating to assigned projects
- Develop schedules and regulatory project plans for key regulatory deliverables on projects under the direction of senior regulatory staff and monitors projects through completion
- Support the preparation and submission of registration documents such as 510(k)s, PMAs, EU Technical Files (CE Mark) and other health authority communications
Qualifications for associate, regulatory
- Production and Review of PRA regulatory returns and key SDPs in accordance with CAD deadlines
- Provide ad-hoc analysis and challenge as required to support management in RWA and other regulatory decisions
- Build strong relationships with stakeholders to ensure output reports are of a high quality and fit for purpose
- Support stakeholders who require analysis and commentary of the business’ capital position
- Update processes / outputs to reflect changes to reporting deliverables in response to mandatory or BAU project changes
- MBA/CA/FRM & PRM is desirable with 6-8 years in Financial Services in a finance role