We Are The People Who Give Possibilities Purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description This position is responsible for managing the various regulatory activities for new and existing combination devices and/or pharmaceuticals including but not limited to healthcare antiseptic products. The ideal candidate is a Regulatory Affairs professional with 5+ years of pharmaceutical and/or combination product experience, strong direct interaction with FDA CDER, demonstrated success leading NDA/ANDA/PAS/CBE submissions, deep knowledge of FDA and global regulatory requirements, and the ability to independently manage complex regulatory projects while partnering effectively across R assure compliance with corporate and external standards and guidance documents. Support the quality system and internal/external audits. Maintain and build upon CDER relationship Guide team on Pharma/Combination product regulations, processes Cross functional collaboration Relationship building Experience Minimum of 5 years’ experience in Regulatory Affairs in Combination Products and/or Pharmaceuticals with experience working directly with the FDA CDER Strong working knowledge of US and International regulations and guidance, such as 21 CFR 820, ISO 13485, ICH guidelines and 21 CFR 210/211 Internal auditing experience a plus 10-20% Travel At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Benefits At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role: Annual Bonus Potential Discretionary LTI Bonus Health and Well-being Benefits Medical coverage Health Savings Accounts Flexible Spending Accounts Dental coverage Vision coverage Hospital Care Insurance Critical Illness Insurance Accidental Injury Insurance Life and AD
Staff Regulatory Affairs Specialist - Pharma employer: BD
Waters is an exceptional employer that fosters a dynamic work culture where innovation meets collaboration. With a strong focus on employee growth, you will have access to ongoing training and development opportunities while working in a hybrid environment that promotes work-life balance. Located in the UK, this role offers the unique advantage of engaging directly with local markets, allowing you to make a tangible impact on customer engagement and sales enablement.
