Director, Global Regulatory Affairs
Director, Global Regulatory Affairs
Industry: Healthcare / Health Services
Job Category: Research & Development
- The Regulatory Affairs Director is part of the Global Regulatory Affairs (GRA) team based in US and will serve as the Global Regulatory Team Lead (GRTL) for assigned programs. He/she is responsible for developing long and short-term planning of regulatory projects that impact the company’s business plan, and developing strategies to ensure effective achievement of regulatory/business objectives.
- Specific responsibilities include:
- Global Regulatory Team Lead (GRTL) will be responsible for developing the global regulatory strategy for the project or projects in his/her remit. In this capacity, the GRTL has regulatory accountability globally for the program, working with the Global Regulatory team (regions, Regulatory CMC, Regulatory Operations, labeling) for developing robust regulatory strategies.
- •Represents Global Regulatory Affairs (GRA) as a member of the cross functional project team and provides regulatory input for the project(s) globally. In this capacity, the GRL is the single point of contact for the business and R&D on regulatory issues for the project. The GRTL will work closelywith members of the Global Regulatory Team (CMC, operations, regions, labeling), and may ask members of the Global Regulatory Team to participate in cross function project team meetings on an agenda driven basis.
- •The GRTL will ensure development of robust regulatory strategies for the program and will be accountable for developing and maintaining a regulatory strategy document. The regulatory strategy document will evolve over the course of a project’s development, but should include the overall regulatory strategy and how it will deliver on the TPP, regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies. The GRTL will work with the global regulatory team to ensure that relevant input from all GRA functions is vetted and included in the regulatory strategy.
- •The GRTL is accountable for ensuring that all GRA peer reviews are conducted in a timely manner ahead of key governance meeting and major (issue driven) ad hoc reviews by Sr. Management. The GRTL is also accountable for ensuring that GRA Sr. Management is aware of any major issues with the project, including any changes to risks.
- •The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and Target Product Profile (TPP). The GRTL will also work with the labeling strategist and regions to develop region specific labels.
- •The GRTL, working with the regions, will also interact directly with HAs as needed for the project.
- •The GRTL will work transversally to ensure a properly functional Global
- Regulatory Team and provide an environment and venues under which all GRA team members and functions have a voice.
- •The GRTL will ensure communications from HAs are properly communicated to the business and up through GRA Sr. Management. The communication of any HA feedback should be interpreted and the impact on the project assessed.
- •Assess the accuracy and appropriateness of submissions to regulatory authorities to support successful clinical trial applications and/or marketing authorizations.
- •Provide regulatory due diligence assessments of new business opportunities as required
- •The GRTL will line manage, and/or coach mentor, junior staff supporting the program.
- •Depending on the program assignment, GRTL may also serve as the US Regulatory Lead and responsible for developing and implementing the US regulatory strategy. The US lead will serve as the primary FDA contact as needed and will represent the US regulatory position to senior management governance committees as needed.
- 7years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5years working in regulatory affairs (regionally or globally).
- Experience in other relevant functions will be considered.
- Delivery of at least one major application (NDA/BLA/MAA/JNDA etc…), or extensive experiencewith late stage development/marketed products.
- BS in a scientific discipline.
- Advanced degreepreferred.
Knowledge, Skills and Other Experience
- •Extensive knowledge and understanding of complex medical and scientific subject matter as well as evolving FDA policy and guidance related to advertising and promotion topics.
- • Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
- • Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
- • Excellent operational skills including planning, organizing and ability to motivate and lead others.
- •Ability to work well within cross-functional teams
- •Can demonstrate solid oral communication and writing skills
- •Understanding of the Global and U.S. pharmaceutical market place and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
- •Develops collaborative relationships to facilitate the accomplishment of work goals
- •Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
- •Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
- •Can build networks to obtain cooperation without relying on authority
- •Strong sensitivity for a multicultural/multinational environment
- •Unquestionable ethics, professional integrity, and personal values consistent with values
Security Clearance Required: No
Visa Candidate Considered: No
Full-time Benefits - Full
Relocation Assistance Available - Possible for ideal candidate
Bonus Eligible - Yes
Interview Travel Reimbursed - Yes
- 5+ to 7 years experience
Seniority Level - Director
Management ExperienceRequired - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally