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.

• Aid in predicting shifts in the regulatory landscape and approval necessities.

• Support in recognizing regulatory pathways and approval criteria for designated programs, including regional variations.

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

• Facilitate clinical development and commercialization of drug and delivery device combination products.

• Draft filings such as INDs/CTAs and amendments, NDAs/MAAs and supplements/variations, regulatory designation requests, and lifecycle management submissions.

• Compose and coordinate responses to inquiries from health authorities.

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

• Assist with clinical trial execution necessities, including registry postings, essential document packages, informed consent evaluations, document redactions, translation supervision, and daily regulatory inputs.

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

• Cultivate relationships with regulatory agencies while preparing for and engaging in meetings and interactions with health authorities.

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

• Establish relationships with pertinent stakeholders within the assigned disease area.

• Summarize and relay health authority correspondence to regulatory leadership and project teams.

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

• Support regulatory functions such as RA-CMC, Device RA, Regulatory Operations, and Advertising/Promotion.

• Represent Regulatory in study team meetings and escalate issues when necessary.

• Assist in the creation and application of SOPs for regulatory affairs, clinical research/trials, and associated 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 managing regulatory submissions and clinical trial execution within the bio-pharma sector.

• Background with a small-to-midsize biotechnology company and/or drug-device combination products is preferred.

• Willingness to travel for business 10-20% as needed.

• Proficient understanding of global regulatory requirements for clinical development and commercialization.

• Capacity to interpret and apply changing guidance to program execution under the supervision of regulatory leadership.

• Familiarity with drug development and combination product development is advantageous.

• Experience with global regulatory submissions, including US FDA and EMA, in support of pre- and post-approval initiatives.

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

• Exposure to global clinical trials and GxP and ISO/EU MDR requirements for combination products.

• Experience in supporting interactions with global regulatory agencies.

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

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

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

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

• Outstanding organizational skills with the capability to manage multiple deliverables and conflicting priorities.

• Strong analytical skills in assessing regulatory risks and supporting mitigation strategies to meet business objectives.

• High degree of integrity, sound judgment, and dedication 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 employer.

• Reasonable accommodations for qualified individuals with disabilities.