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WELCOME

As the chair of the RAPS Texas Chapter, I'd like to personally welcome you to the RAPS community! By being a member of RAPS, not only are you connected to 14,000+ regulatory professionals worldwide, but you also have access to a vibrant regulatory community right here in your geographic region.

The RAPS Texas Chapter conducts a number of professional development and networking activities throughout the year to help members connect, build relationships and increase knowledge, competence and performance. RAPS is a volunteer-driven organization, and I’ve found that the more I put into it, the more I get back. There are a number of volunteer opportunities available at the chapter and national levels, and I am happy to help you identify something that meets your interests and serves your personal growth needs.

If you are a RAPS member, log in for full access to the chapter member directory and the discussion board. Members residing outside of the chapter served region can find and join a chapter's online community from the chapter community listing.

We hope you will join us at our next event. I look forward to introducing you to some of our other members and volunteers. Again, welcome to RAPS and please let me know if I can be of assistance.

Sincerely,

Dr. Evangeline D. Loh, RAC, PhD
Chair, Texas Chapter

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Chapter Discussion Board

Member Spotlight

Member Spotlight
Each month, RAPS turns the spotlight on a member making an impact in RAPS and on the regulatory community. These members are the backbone of the Regulatory Affairs Professionals Society and an inspiration for others. If you are interested in being highlighted or nominating another member for the spotlight, please contact Austen Gage at agage@raps.org.

Local Regulatory Job Openings

  • San Fernando, California, Pharmavite, LLC has an oppty in San Fernando, CA for a Quality Contrl Supvr. Mail resume to Attn: HR, 8531 Fallbrook Ave, West Hills, CA 91304; Ref #SFNMI. Must be legally auth to work in the US w/o spnsrshp. EOE
  • Tampa, Florida, Biotech Research Group is a scientific and regulatory consulting firm located in Tampa, Florida, position can be remote. Our firm serves clients around the globe in the pharmaceutical, biologics and medical device industries. We have an opening on our team for someone who can primarily provide regulatory submission services to our clients both in the medical device and pharmaceutical arenas. The ideal candidate will have expertise in a multitude of regulatory submission types, including pharmaceuticals with a strong background in the medical device industry.   Summary of Position: You have the opportunity, to join Biotech Research Group as a Regulatory Expert and be part of a talented and dynamic team. In this important and exciting role, you will be responsible for executing US regulatory submissions for our medical device and pharmaceutical clients. Reporting directly to the VP of Regulatory Affairs, you will partner closely with other BRG team members.  If you are a RAPS professional who is looking to work remote or work in Tampa, this could be the perfect opportunity for you!   Specific Job Responsibilities: Act as a team player– someone who is positive, forward-looking, accountable, action-oriented, and focused on delivering results Provide expertise to develop and implement complex regulatory strategies throughout the product lifecycle that are consistent with goals and objectives Prepare and review FDA submissions and other regulatory documents including Pre-Subs, 510(k)s, Special 510(k)s, PMAs, PMA Supplements, PMA Amendments, De Novo, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), Humanitarian Use Device (HUD) Applications, MDRs, and various annual, periodic, and/or study reports Strategize and develop regulatory plans and documents for products, product updates, manufacturing process changes, marketing materials, and clinical trials Assess and review client’s medical device files for regulatory requirements mainly for US and European markets Utilize knowledge of regulatory requirements applying to manufacturers’ processes and products Review product design, documenting any deficiencies, review engineering and manufacturing Create reports for clients utilizing analytical skills, technical knowledge and excellent written communication skills Respond to inquiries immediately  Acquire new accounts Work with minimal supervision while obtaining project objectives Possible travel depending on project Supports product recall and removal planning, execution, and tracking Maintains current knowledge of FDA medical device regulations and guidances Assist with FDA submissions for Pre-IND, IND, ANDA, OTC, DMF Required Knowledge, Skills, and Abilities: Minimum Master's scientific-related degree required (doctorate preferred) Minimum of 10 years of experience with Medical Device industry and directly working with and being responsible for Regulatory Affairs/Submissions to FDA (additionally, EU submissions helpful) Thorough knowledge and demonstrated ability to successfully submit documents related to Pre-Subs, 510(k)s, Special 510(k)s, PMAs, and De Novo requests Knowledge of engineering and technical applications used in the development of medical devices is helpful Excellent interpersonal, verbal, written and presentation skills.  Must work well in project teams Strong analytical skills while handling multiple projects, delivering results on time using well developed problem-solving skills Pro-active attitude and excellent organizational skills and the ability to work autonomously Experience with FDA submissions for Pre-IND, IND, ANDA, OTC, DMF   Bonuses with new procured accounts
  • Richmond, Virginia, Have 10 years of leadership experience in quality systems and operations with the FDA or in an FDA regulated environment? Have a passion for driving excellence and compliance in everything you do? If so, we want to speak with you!  We are currently seeking a  Manager, Regulatory Quality Compliance  to join our Regulatory Quality Audits & Requirements department in  Richmond, VA. This role will work with multiple business partners to prepare for FDA Tobacco Product Manufacturing Practice (TPMP)’s. You will collaborate with quality, manufacturing, and product development personnel to evaluate their quality systems and product processes. In this role, you will: • Generate TPMP gap assessments of existing processes and systems against Altria Quality Requirements (AQR) using multi-disciplined, multi-functional teams. Plan and conduct research on good manufacturing, good laboratory, good clinical practices, and product development requirements pertinent to FDA regulated industries to support the development of Altria Quality Requirements (AQR), Quality Management System (QMS) and general quality practices • Lead enterprise FDA Inspection Readiness Plans to support TPMP readiness activities. Develop proficiency in industry proposed TPMPs. Generate and lead project plans to address remediation plans. Generate metrics to track project progress • Develop, lead, and write position papers which define the rationale for TPMP response and interpretation • Conduct trend analysis and formulate management communications for emerging quality risks related to TPMPs • Craft and improve quality requirements and standards through independent research and interpretation of other FDA regulated industries and standards • Provide mentorship and recommendations to management on tobacco Manufacturing Practices (TPMP) implementation and issues resolution • Lead Quality Compliance activities with respect to TPMP readiness • Participate and/or lead QMS audits • Provide TPMP Quality Compliance support for Vendor and Supplier Management, including, but not limited to, Contract Manufacturing Organizations, Contract Labs, Quality Agreements, QMS infrastructure, and risk management • Advise on internal and external situations which may pose quality/compliance risks that may adversely affect business operations • Conduct analyses, consulting and assessments of various operations and processes by applying their knowledge and judgment in areas where they may have little to no previous work experience • Lead or participate in corrective actions and programs designated to improve the quality and compliance posture of the organization • Maintain confidentiality of information acquired during audits We want you to have: • Bachelor's degree in a Physical Science, Engineering or related field • Minimum of 10 years of leadership experience in FDA and or FDA regulated quality systems and operations (pharmaceuticals, medical devices, and dietary supplements). Experience in product development preferred. • Working knowledge of Data Integrity and product development related requirements. • Strong analytical and organizational skills • Strong written, verbal and presentation skills along with proven ability to collaborate with others • Ability to considerately, independently and persuasively provide critical and sensitive feedback to the most senior levels of management • Proficiency in conflict negotiation and resolution is preferred • Perform assignments in an independent and autonomous manner with minimal direct supervision • Able to utilize various computer software to include: Word, Excel, PowerPoint, and Outlook • Comfortable working during non-core hours as required to assess multiple shifts and operations spanning lengthy periods At Altria Client Services, we recognize that our people are the reason we achieve our business goals. We believe in developing the leadership potential of our employees by providing them with opportunities for training, development, and advancement.