The Associate Director/Director, Regulatory Affairs provides regional (north America and Canada) strategic implementation support for all regulatory activities related to the ongoing development, registration, and life-cycle management of Imetelstat and future Geron development product candidates. This position holds direct and supportive responsibilities within the areas of regulatory strategy, submissions, health authority interactions, and product labeling. The Associate Director, Regulatory Affairs will interact closely with corresponding functional team members and executives within the company. The position reports directly to the Vice President, Global Regulatory Affairs.
Depending on the location of the candidate, this position may be located in either the New Jersey or California office.
Regional Regulatory Strategy Implementation
- Responsible for the development of strategic implementation plans.
- Understands regional and local requirements and advises the Global Regulatory Head on implementation issues pertaining to regional regulatory strategies.
- Responsible for the implementation of the regional regulatory strategy, including the regulatory submission plans, in line with agreed business objectives.
- Incorporates supply chain strategy into registrations in the regions.
- Develops and updates contingency plans for the execution of regional regulatory strategies and refines regional plans as new data become available.
- Facilitates tactical implementation at the regional level and ensures ongoing and effective communications with the regional and global teams on product activities and issues, related to strategic execution.
- Provides input on implications for regional & global regulatory strategy through participation in other product-related teams and provides team leadership where appropriate.
- Keeps abreast of changing regulatory landscape to deliver knowledge management to the organization. Contributes to a strong knowledge management base.
- May be required to support additional regulatory projects (e.g. conducting due diligence, supporting regulatory new initiatives) as needed.
Health Authority and Operating Company Interactions
- Basic understanding of worldwide health authorities and applicability of procedures to the regions.
- Participates in the preparation for meetings with regulatory agencies in the regions.
- Responsible for the preparation and provides review and input on documents for submission to Health Authorities in the regions.
- Responsible for the preparation of registration dossiers (e.g., International Common Technical Document (iCTD) and ASEAN Common Technical Document (ACTD).
- Works with project teams and leadership to develop regional marketing approval submission plans and timing.
- Manages and tracks country-specific requirements for local submission purposes (e.g., legal and technical documents, RMP).
- Responsible for submission tactical planning and timelines, including submission plans for the products’ life cycle, and communicates to relevant groups.
- Ensures follow-up of regulatory dossier after submissions.
- Oversees management of responses to questions asked by Health Authorities in a timely manner and in line with the product strategy.
- Provides strategic input to IND/CTA dossier content, scope and timing.
- Contributes to the management of product lifecycle submissions (e.g., PSURs).
- Oversees development of labelling negotiation strategies for countries in the region and development of supporting documentation for labelling.
Regulatory Input into Other Functions
- Engages Head of Regulatory, ex-US regulatory colleagues and representatives from other development functions to enable execution of regional strategies.
- May have oversight of external regulatory contractors/consultants.
- A minimum of Bachelor’s degree (or equivalent) in a scientific discipline is required.
- An advanced degree (MS, PhD, MD or PharmD) is highly desired.
- A minimum of 8-10 years of relevant experience with a Bachelor’s degree is required OR Masters/PharmD 6-8 years; PhD 4-6 years is required.
- A minimum of 6-8 years of Pharma regulatory experience with a Bachelor’s degree is required OR Masters/PharmD 5-6 years; PhD 5 years.
- Breadth of global regulatory affairs experience in global drug development and commercialized products (for example, experience in a therapeutic area, multiple phases of drug development) is required.
- Regulatory experience in North American geographic region preferred, with prior global regulatory exposure/experience.
- Additional experience specifically in AP, LA or non-EU countries is desirable.
- Good working knowledge of regulations and guidelines related to drug development and registration; Understanding of the impact of laws, regulations, guidance, rulings, and precedents on drug development; knowledge management skill and experience is desirable.
- Demonstrated contribution to drug development projects and implementation of strategies is desirable.
- Demonstrated ability to handle multiple projects, excellent verbal and written communication skills, ability to work and thrive in a multi-cultural environment, and ability to work in a matrix environment are required.
- Experience in working/leading project teams; demonstrated project management skills is required.
- Excellent English verbal and written Communication Skills.
- Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones.
- Must be available for periodic face-to-face meetings between US sites, which may require travel to the other Geron sites. Occasional overnight travel within US - less than 10%.