Senior Regulatory Affairs Specialist

Description

We are the makers of possible

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.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Job Responsibilities :

Understands and has expertise in US Pharmaceutical and OTC Monograph regulations and develops different regulatory pathways and communicates options to cross functional teams.

Provides regulatory guidance for one or more program(s), including participation in external Food and Drug Administration (FDA) meetings, internal core team meetings and providing technical guidance on complex regulatory issues.

Creates and manages programs with multiple workstreams and identifies key dependencies and critical path items.

Develops and leverages working relationships with key personnel / representatives from FDA and oversees communications with regulators.

Work with functional representatives from other areas such as R&D, Manufacturing, Medical Affairs, and Quality to review and provide input on regulatory strategy for new products and regulatory impact assessment for product changes.

Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.

Review CMC changes and determine regulatory reporting category in accordance with FDA guidance for changes to an approved (A)NDA

Write domestic device and drug regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND, IND Amendments and Regulatory authority responses.

Assess necessity for reporting changes to FDA for device modifications. Prepare robust justifications for changes that do not require notices. Address and resolve requests for additional information.

Determine deliverables for regulatory submissions and communicate to appropriate functional representatives to ensure timely and accurate submissions per business objectives.

Support OUS RA team members in order to maintain effective collaboration and to synchronize domestic and international submissions.

Review and Approve Labeling and Advertising and Promotional materials for compliance to internal procedures.

Manage and maintain the drug registrations and listings (CDER Direct / eDURLS) system and complete CARES Act reporting.

Support the submission of SPL via ESG / CDER Direct for all drug labeling in the US.

Evaluate and prepare procedures pertaining to corporate and departmental regulatory activities.

Monitor applicable regulatory requirements; assure compliance with corporate and external standards and guidance documents.

Support the quality system and internal / external audits.

Education and Experience :

Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a minimum of five years of experience, with demonstrated support of regulatory submission development and approval from the FDA and other global regulatory agencies.

Excellent organizational and communications skills.

Experience with MS Word, Excel, PowerPoint, and Adobe Acrobat PRO required. Experience navigating FDA databases required. Experience with EU MDR preferred.

Experience with electronic submissions and ERP systems is preferred.

Knowledge and Skills :

Required Qualifications :

Proficient in using Microsoft Word, Excel, PowerPoint, and OneNote.

Strong communication (written, oral) and project management skills.

Ability to plan and schedule multiple priorities in a concurrent fashion.

Ability to review, collate and summarize scientific and technical data.

Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.

Excellent problem solving and analytical skills.

Excellent written and oral communication skills with ability to effectively communicate at varying levels in the organization.

Experience with authoring NDAs / ANDAs. (CTD Format)

Experience authoring and managing regulatory submissions and / or registrations, with responsibility for communicating with regulatory authorities.

Experience facilitating and designing communication strategies to FDA.

Preferred Qualifications :

Advanced degree

Experience with regulatory tools and systems. (CDER Direct / eDURLS)

Knowledge / Expertise of Quality Systems.

Proven background managing complex and strategic regulatory projects from initiation to conclusion.

Detail-oriented, methodical and able to handle regulatory information and submissions with a high degree of accuracy.

Previous experience facilitating meetings with FDA, reviewing submissions, registrations and / or notifications from varying product lines or programs.

Physical Demands :

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.

Work Environment :

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

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.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health.