Sr. Manager, CMC Regulatory Affairs

San Diego, CA, United States
Oct 02, 2019
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Job Purpose:

The Senior Manager will lead regulatory activities across the Antibody Therapeutics Business Unit. They will serve as the regulatory representative on Project Teams where they will provide regulatory strategy, direction, support and advice to the teams. The Senior Manager will lead the development of a sound regulatory strategy and follow-through to implementation to assigned project teams. The Senior Manager will take the lead on all regulatory activities, including the management of authoring, review, and coordination of a quality submission. They will prepare the team for meetings, teleconferences, and other communications with FDA and other global regulatory agencies. The Senior Manager will educate teams regarding regulatory risks and implications for strategy, product/process development, and/or post approval change activities, and use technical knowledge and effectively apply regulations and guidelines to the assigned projects.


-Represent Regulatory Affairs on assigned product/ project teams to communicate regulatory strategy and plans to gain alignment with team members, line management, and multiple stakeholders

-Develop innovative regulatory strategies that incorporates risk identification and mitigation

-Lead the preparation, planning and execution of aligned regulatory strategy through timely regulatory submissions

-Oversee development of submission content, documents and timelines

-Provide critical review of all documentation supporting regulatory applications, provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management

-Lead meetings both in-person and teleconferences with regulatory agencies for specific projects; may also be required to work with government funding agencies

-Negotiate complex issues with regulatory agencies and prepare responses to questions and comments from regulatory agencies

-Ensure regulatory product compliance for assigned products (e.g. agency commitments)

-As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance

-Interact with company partners and consultants for various regulatory matters as needed

-As required, develop procedures to support the regulatory affairs department

-May provide input to business unit strategies from regulatory perspective

-May be responsible for a functional area and/or have direct reports

Education, Experience & Skills:

-Bachelor's degree in a life sciences or related discipline required; advanced Degree (MS or PhD) highly preferred. Ideally a minimum of 10 years directly related experience in biotechnology or pharmaceutical industry. Minimum of 8 years direct experience in Regulatory Affairs.

-Must have product development and/or post licensure experience within Regulatory Affairs; experience with biologics and vaccines is preferred

-Must have experience interacting with the FDA, EMA, Health Canada and/or other regulatory agencies

-Ability to work on problems of diverse scope

-Identifies priorities and key issues in complex situations and solves with minimal assistance

-Exercises judgement within generally defined regulatory practices and policies

-Experienced in leading cross-functional interactions related to regulatory matters

-Effective in both written and oral communication

-Able to direct work as required and manage complexity

-Thorough knowledge of the development of one or more types of Health Authority regulated products (drugs, biologics, medical devices, combination products)

-Ability to anticipate and prevent potential issues

-Understanding of regulatory issues and their touch points

-RAC certification would be a plus