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Company

Original Job Post

myGwork - LGBTQ+ Business Community · 3 days ago

Sr Manager, Regulatory Affairs

Carlsbad, CA

Full-time

Onsite

Senior Level

$118K/yr - $177K/yr

7+ years exp

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Responsibilities

Responsible for providing guidance to assure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements.

Oversee ad/promo reviews to ensure regulatory compliance and support New Product Introduction (NPI) projects, ensuring they align with regulatory requirements and company policies.

Serve as a SME on various regulations and coordinate regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.

Organize and conduct training sessions to enhance the team's knowledge of working in a regulated environment.

Provide support and guidance across divisions. The delivery of regulatory guidance to project teams and external partners will be key activities toward assisting the Company in achieving its business goals.

Implement strategies for product submissions, facilitate and prepare U.S. regulatory Pre Submission or submission documents, and lead FDA pre submission and submission meetings.

Support and guide team members through submission and support global regulatory registration representatives for product registration activities.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory affairsPharmaceuticalBiologics vitro diagnosticsMedical devicesBla510(k)PmaCe ivd submissionsRegulatory strategyDesign controlCgmpQuality systemsImport/export requirementsProject managementManagerial competenciesQuality managementProblem-solvingHard-working communicatorContinuous improvement mindset

Required

Bachelor degree in Biology, Chemistry, bio-engineering, or related science required.

Minimum of 7-10 years Regulatory Affairs experience in Pharmaceutical, Biologics, In vitro diagnostics, or Medical Devices. This experience must include either BLA, 510(k), PMA, CE IVD submissions.

Well versed in the aspects of regulatory strategy creation, design control, cGMP/quality systems, and import/export requirements.

Experience as the RA representative on project core teams providing regulatory guidance and RA strategies.

Managerial competencies in leading impactful teams, demonstrating strong decision-making skills, and the ability to prioritize and deliver on multiple projects simultaneously.

High energy level; positive attitude; works well under stress, Strong communicator and leader. Hands-on, willing to take action, and able to implement effectively through their team.

Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency.

Ability to provide solutions based on knowledge of regulation and experience.

Willingness to travel (~10-15%).

Benefits

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount