Regulatory Affairs Manager Job Description
Regulatory affairs manager
provides support in formulating and implementing regulatory strategies for the development of Oral solids generic products and regulatory activities in line with US FDA and ICH guidelines.
Regulatory Affairs Manager Duties & Responsibilities
To write an effective regulatory affairs manager job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory affairs manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Maintaining up-to-date knowledge and expertise of FDA regulations/guidance documents, and ICH guidelines
Coordinating FDA meeting requests, meeting rehearsals, briefing book preparations and preparing meeting minutes of FDA meetings
Oversees the preparation and maintenance of regulatory submissions and files for Wave 1 (US and EU) countries including US PMA submissions
Functioning as a liaison between FDA and company for assigned projects
Conducting regulatory communications with FDA, under appropriate supervision and direction, for assigned products and activities
Manage electronic submissions to FDA in eCTD format
Maintain and improve working knowledge of current/pending regulations and guidance for generic drugs and new drugs to ensure compliance with Regulatory Agency requirements
Monitors the development and assesses the impact of new and proposed changes in laws, court rulings, lawsuits, regulations and enforcement activities impacting the use of ingredients, product safety, labeling and advertising
Lead and manage activities concerned with the submission and approval of products and product transfers to government regulatory agencies including US and EU regulatory agencies
Customizes Company Core Data Sheet (CCDS) to local PI as per local regulations
Regulatory Affairs Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Affairs Manager
List any licenses or certifications required by the position: RAC, MDD, US, RAPS, MDR, FDA, CE, FTA, GMP, ETL
Education for Regulatory Affairs Manager
Typically a job would require a certain level of education.
Employers hiring for the regulatory affairs manager 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, Pharmacy, Biology, Technical, Education, Life Sciences, Medical, Life Science
Skills for Regulatory Affairs Manager
Desired skills for regulatory affairs manager include:
ICH and other global regulatory guidelines
CMC
FDA
Clinical
ISO 13485
Regulations
US
Experience in regional regulatory environment in relevant product area and development stage
AUS and CAN and corresponding guidelines
Medical device regulations
Desired experience for regulatory affairs manager includes:
Any materials produced by patient organisations which are planned for distribution by representatives to healthcare professionals, and any materials for display at patient organisation meetings
Local sponsorships to ensure compliance in close collaboration with QA and compliance team
3 – 7 years of experience in environmental compliance and hazard assessment
BA/B.S in a scientific, healthcare or related field or equivalent experience
Some travel within regional responsibility is required
5-10% travel required, with some international travel
Regulatory Affairs Manager Examples
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Regulatory Affairs Manager Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of regulatory affairs manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory affairs manager
- Ensures accuracy of US registration and device listing
- Prepare the monthly Legislative and Regulatory forum and pack to provide the stakeholders brief about the new regulations and its requirements
- Assist RA in developing regulatory strategy for upcoming projects
- Manage submitting Drug Listing and SPL/PLR submissions
- Manage and review change control documents, batch records, and other technical documents
- Evaluate changes in regulatory environment and standard
- Oversees the preparation and maintenance of regulatory submissions and files
- Ensures compliance with SOPs
- Manages goals and objectives of the RA department in alignment with AP&LA regulatory affairs, regional and country business goals and objectives
- Plans, prioritizes, and manages resources of regulatory activities in alignment with objectives
Qualifications for regulatory affairs manager
- Strategic thinking hands-on experience with different registration procedures
- Completion of industry courses
- Previous experience in regulatory affairs (minimum 3 years) in the region in a food/chemical company or in Quality management or in any related field
- A Bachelor's degree and a minimum of 5years of experience in regulatory affairs is required
- A Bachelor's degree is a scientific discipline and an advanced degree / RAC is desirable
- Global regulatory affairs and compliance experience is required
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Regulatory Affairs Manager Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of regulatory affairs manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory affairs manager
- Provide regulatory training to site staff, FSE/FAS, including QSR, local regulations
- Assesses and communicates regulatory requirements for submissions and programs to ensure that all development activities are in compliance with applicable regulations and guidelines
- Insure all consumer brands packaging is in compliance with federal, state and local regulations
- Coordinate activities, define timing, and create registration files to support new product registrations maintanence of approved biologicals, pharmaceuticals, bio-pharmacueticals, or other regulated products in CALAR markets
- Build strong regulatory and technical internal expertise
- Master the complexity of the Regulatory framework in the EME region and across countries in order to insure tight coordination and consistent decision making across and within products
- Support CP & SAS regulatory organization with the coordination of Bio-efficacy dossiers
- Author and review departmental SOPs, any additional SOPs that may impact Regulatory affairs
- Perform due diligence audits of applications proposed for transfer from external partners
- Analyzes reports and metrics from tracking tools
Qualifications for regulatory affairs manager
- Direct experience with global regulatory submissions is required
- Proven leadership and project management skills are desirable
- Up to approximately 25% international and domestic travel may be required
- Experience in QA/QC
- Demonstrated leadership and contribution to drug development strategies
- Demonstrated ability and flexibility to handle multiple projects and strict timelines
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Regulatory Affairs Manager Job Description
Job Description Example
Our growing company is hiring for a regulatory affairs manager. 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 regulatory affairs manager
- Working with global and local stakeholders to ensure optimisation of MA submissions and their compliance with regulations and any other local requirements
- Independently authors, develops, complies, reviews, maintains and submits high-quality excipient and API Common Technical Document (CTD) and Drug Master Files (DMF’s) with regulators (FDA, EMA )
- Monitors regulatory developments in the pharma area, and work with plants to roll out new FDA and IPEC requirements
- Represents BDDS Molecular Diagnostics RA Function as the new product development Core Team Member
- Represents BDDS Molecular Diagnostics RA function in interactions/negotiations with U.S. regulatory agencies and additionally enables and empowers staff to interact and negotiate with regulators
- Identifies opportunities for continuous improvement that have a significant impact (cost, cycle time, quality, ) and assists in developing or executing implementation plan
- Manages the preparation and filing of premarket submissions and Technical Files
- Hires, develops and retains staff to meet business needs and to create a pipeline of talented professionals for progressively challenging and responsible roles
- Develops direct reports with regard to required competencies, including, but not limited to, regulatory knowledge and ability to apply this knowledge, effectiveness in team and one-to-one interactions, and verbal and written communications
- Provides recommendations for BDDS Molecular Diagnostics RA functional budget
Qualifications for regulatory affairs manager
- You have good knowledge of software development requirements (IEC 62304 and IEC 62366) standards for electrical products such as IEC 60601
- Bachelor’s degree (BS/BA) in any biological science
- Manage external vendors and partnerships
- Minimum 5-year experience in a regulatory capacity with a Class II or higher complexity medical device
- Master degree in Pharmacy, Biology or Veterinarian (or similar)
- Experience in Regulatory Affairs is considered a plus
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Regulatory Affairs Manager Job Description
Job Description Example
Our innovative and growing company is looking for a regulatory affairs manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory affairs manager
- Represent CMC Regulatory viewpoint and expertise on the CMC Team, Global Regulatory Team, including regulatory risk assessments and mitigations associated with proposed strategies
- Establishing, maintaining and supporting the processes required for the Regulatory Affairs US and EU compliance related activities
- Develop and execute global CMC regulatory strategy for product (s)
- Confirm CMC strategy is in alignment with Therapeutic Area, regional strategies, commercial strategy, and Target Product Profile
- Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed
- Compile, edit, and submit regulatory submissions together with their amendments and supplements to FDA and other regulatory agencies
- Remain cognizant of important developments in FDA and other regulatory agencies that may impact product line
- Deal appropriately with the compliance issues and escalate those issues in an appropriate manner to Head of Regulatory Affairs & Head of Compliance
- Participate in managing the Central Bank of Egypt inspection audit, which occurs every two years, and challenge CBE auditors about the validity of the issues raised
- Undertaking timeous alert circulation and implementation of new policies and procedures
Qualifications for regulatory affairs manager
- Minimum six years of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s)
- Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders
- Ability to think strategically, and to interpret and act upon complex or ambiguous issues, in both the immediate and broader context
- Ability to inspire, motivate, and build the confidence of teams to reach goals, steadfastly pushing self and others to achieve results
- Demonstrates leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed
- Demonstrates in-depth understanding of advanced technical/scientific principles that relate to a specific product line
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Regulatory Affairs Manager Job Description
Job Description Example
Our growing company is looking for a regulatory affairs manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory affairs manager
- Responsible for fostering and maintaining the compliance relationship between PHP compliance staff and CMS Region 10 account management personnel
- Oversees the development and continual improvement of PHP compliance structures regarding commercial products, including development of documented policies and adherence to requirements related to downstream delegated entities
- Responsible for managing 5 direct reports, including hiring, coaching, development, and discipline
- Consults with managers and staff to establish administrative procedures that meet all state and federal compliance requirements and to resolve related problems as applicable to PHP’s commercial lines of business
- Develops and delivers educational presentations regarding commercial policy and regulatory issues to internal and external audiences
- Provide professional advice and guidance on national, EU and international RA and PV & S processes and procedures to internal and external customers, using judgement and creativity to suggest the most appropriate course of action where appropriate, and ensuring complex and conceptual issues are understood
- Take responsibility for RA and PV & S for individual projects, solving issues independently when they arise and where they fall within set role objectives
- Investigate and analyse specific issues within RA and PV & S, creating recommendation reports, supported by advances in regulation or recognised good practice
- Ensure that the provision of RA and PV & S are delivered to the Centre, proactively changing the delivery according to requirements
- Manage the operation of a team of PV & S specialists, planning, organising and delegating work, monitoring progress and intervening as required
Qualifications for regulatory affairs manager
- Ensure regulatory compliance for all innovation activity in N&H and advise on regulatory options and solutions
- Lead in maintaining product life cycle
- Monitor and analyze regulatory trends, ensure adherence to established regulatory guidelines
- Participate in product stewardship reviews
- Provide expert and timely knowledge on regulatory compliance, risks and opportunities to broader Regulatory Organization (regional and global teams)
- Consistent proactive and problem solving mindset putting internal and external customer’s priorities at the core