Senior Manager, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the formulation and execution of global regulatory strategies while contributing to the planning of development programs.

• Help identify regulatory pathways and approval criteria for designated programs, taking regional variations into account.

• Prepare, review, coordinate, and oversee global regulatory submissions carried out by CROs across the US, Europe, APAC, LATAM, and other relevant regions.

• Support submissions such as INDs/CTAs and amendments; NDAs/MAAs and supplementary variations; regulatory designation applications; and lifecycle management filings.

• Draft and coordinate responses to inquiries from health authorities.

• Ensure submissions align with global eCTD and combination product specifications.

• Support the execution of clinical trials, which includes developing registry postings, preparing essential document packages, reviewing informed consents, overseeing document redactions, translations, and daily regulatory inputs.

• Manage routine regulatory submissions, including DSURs, IND Annual Report appendices, NDA Annual Reports, PADERs, and investigator information.

• Foster relationships with regulatory agencies, including preparing for and participating in meetings and interactions with health authorities.

• Maintain an up-to-date understanding of regulatory policies, guidance, and environments.

• Build strong relationships with relevant stakeholders within the designated disease area.

• Accurately and promptly summarize and communicate correspondence from health authorities to regulatory leadership and project teams.

• Collaborate with Clinical Development/Operations, Safety, Project Management, CMC, Commercial, and Medical Affairs teams.

• Facilitate regulatory activities for assigned assets, including RA-CMC, Device RA, Reg Ops, and AdPromo.

• Represent Regulatory in study team meetings and escalate issues to regulatory leadership as necessary.

• Aid in the development and implementation of SOPs for regulatory affairs, clinical research/trials, and related activities.

⛳️ Requirements

• A Bachelor's degree in life sciences, engineering, biology, or a related field is required.

• At least 5 years of industry experience with progressively increasing responsibilities in regulatory affairs is required.

• Experience in managing regulatory submissions and clinical trial execution within the bio-pharma sector is essential.

• Preferred experience in a small-to-midsize biotechnology company and/or with drug-device combination products.

• Willingness to engage in business travel, up to 10-20% as necessary.

• Working knowledge of global regulatory standards for clinical development and commercialization is essential.

• Capability to interpret and apply evolving guidelines to program execution under the guidance of regulatory leadership.

• A foundational understanding of drug development and combination product progression is advantageous.

• Experience with global regulatory submissions, including those to the US FDA and EMA, supporting both pre- and post-approval programs.

• Experience in LATAM and Asia (i.e., China) is a plus.

• Familiarity with global clinical trials and GxP/ISO/EU MDR requirements for combination products.

• Experience in facilitating interactions with global regulatory agencies.

• Familiarity with document management systems (e.g., Veeva RIM) is a plus.

• Ability to cultivate effective working relationships with both internal and external stakeholders.

• Strong skills in cross-functional collaboration, with experience in supporting alignment within a matrixed environment.

• Excellent interpersonal, verbal, written, and presentation skills for communication with internal and external stakeholders.

• Exceptional organizational skills, capable of managing multiple deliverables and competing priorities.

• Strong analytical skills for evaluating regulatory risks and supporting mitigation strategies to meet business objectives.

• A high level of integrity, sound judgment, and a strong commitment to compliance.

🏝️ Benefits

• Competitive compensation package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Short-term disability (STD).

• Long-term disability (LTD).

• 401(k) Savings Retirement Plan.

• Employee Stock Purchase Plan (ESPP).

• Equal opportunity employment.

• Reasonable accommodations for qualified individuals with disabilities.