Associate Director Regulatory Affairs

Broad Overview

This individual will report into our US Head of Regulatory Affairs and is expected to work out of our US Headquartered office in West Conshohocken on a hybrid schedule with 3 days a week in office.

This individual will be responsible for leading regulatory activities for SERB’s products. To lead, develop, and implement preparation of submissions relevant to assigned products and/or projects to FDA, including providing strategic input into Chemistry, Manufacturing, and Controls (CMC) and cross-functional clinical development programs.

As Associate Director, Regulatory Affairs, your responsibilities will include:

• Development and implementation of regulatory strategy plans according to target product profile and other tools and information.
• Participate as an active member of Global Regulatory Affairs and multi-disciplinary teams to establish regulatory strategies for proposed post-marketing CMC changes, clinical development programs, commercial products, commitments and label expansion. Ensure that the regulatory strategy is aligned with project and business objectives and that deliverables are on time. Identify and communicate potential risks associated with strategy scenarios.
• Represent and coordinate regulatory information as a team member covering CMC, clinical, non-clinical, labelling, and post approval change activities. Provide review and input of documents, protocols, methods, test results and reports.
• Assist in preparation for regulatory FDA interactions and document regulatory contacts with FDA.
• Prepare, maintain and/or coordinate IND and NDA/BLA submissions including amendments, supplements, variations, responses to FDA questions and requests, meeting requests, briefing packages, annual reports, etc. Help manage the internal review and submission of these items.
• Ensure consistency/completeness/accuracy and adherence to regulations and applicable guidelines for all regulatory submissions and manage information and reviews within internal systems.
• Support the preparation of new packaging artwork and review revisions to packaging artwork for compliance with approved labelling.
• Participate in the preparation of corporate Standard Operating Procedures.
• Closely monitor and report relevant changes to local requirements and competitor regulatory information to Global Regulatory Affairs
• Ensuring that all interactions and engagements are carried out in a professional, efficient, courteous manner and that all work is accomplished with quality and in accordance with SERB values.

The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

To be successful in this role, you should demonstrate:

• Bachelor’s degree in life sciences or engineering (I.e. biology, chemistry, engineering, math, pharmacy, pharmacology, statistics), master’s degree preferred
• 8 years’ experience in pharmaceutical regulatory activities with CMC experience and preferred clinical drug development experience in US.
• Experience in biologics required.
• Demonstrated ability to file INDs with the FDA. Experience in EU and devices/combination products are a plus.
• Experience must include developing dossiers and supplements including INDs, BLAs/NDAs, briefing documents, etc. as well as direct interactions with FDA regulatory authorities.
• Excellent interpersonal skills are required.
• Demonstrated problem solving abilities.
• Must have the ability to make recommendations to effectively resolve problems or issues, by using judgment that is in consistent with standards, practices, policies, regulation or guidance from governmental bodies.
• Exceptional verbal and written communication skills including the ability to communicate effectively in a multicultural, multinational, matrix environment.
• Must be self-motivated with ability to effectively manage/prioritize multiple tasks.
• Strong quality and clinical knowledge is mandatory.

Company Benefits

• Hybrid Working
• Vacation, Personal and Sick time
• 15 Paid Company Holidays
• Medical, Dental, Vision and other Voluntary benefits
• Paid Parental Leave
• Tuition Assistance
• Discretionary Bonus Plan
• Competitive 401(k), $1 for $1 up to 6% of pay. The safe harbour match is vested immediately. In addition, SERB also offers a discretionary match of up to 4% of pay which vests 20% a year for 5 years.