Associate Director, Regulatory Writing

POSITION SUMMARY:

Reporting to the Vice President of Regulatory Affairs, this position is specifically responsible for the technical writing oversight of regional and/or global regulatory submissions and ensures strategies are in accordance with therapeutic area direction and corporate objectives.

Regular onsite presence is required to support cross-functional collaboration, team engagement, and business operations. Employees designated as onsite or hybrid who reside within the local commuting area are expected to work onsite at Rigel’s South San Francisco headquarters during normal business hours each Wednesday and Thursday. Employees designated as remote are expected to work onsite during normal business hours for a minimum of two Wednesday/Thursday business-day periods per month, as scheduled with management, and more frequently as business needs require.

Employees designated as onsite or hybrid are expected to be onsite at Rigel’s South San Francisco headquarters during business hours on Wednesdays and Thursdays each week. Employees designated as remote are expected to be onsite during business hours on Wednesdays and Thursdays at least twice per month, and more frequently as business needs require.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Supporting the Head of Regulatory Affairs with strategic regulatory submissions for company milestones.
• Provides regulatory writing in the preparation of regulatory submissions in accordance with ICH and/or global/regional regulatory requirements guidelines.
• Is the primary point of contact for regulatory writing for the cross-functional team in the disease area.
• Writes or coordinates all types of clinical, and regulatory documents, taking a proactive lead role in driving content and scientific strategy.
• Prepares needed regulatory operations Standard Operating Procedures (SOPs); provides regulatory review of SOPs from other departments as necessary.
• Establishes and drives document timelines and strategies.
• Guides or trains cross-functional team members (internal or external) on processes and best practices; coaches or mentors more junior writers.
• Proactively identifies and champions departmental process improvements. May develop and present best practices or innovations to internal or external audiences.
• May lead cross-functional, cross-therapeutic area process improvement initiatives.
• Supports the Vice-President of Regulatory Affairs, Development Leadership and leads discussions in regulatory writing and cross-functional meetings as appropriate (eg, submission team meetings, study team meetings, clinical team meetings).
• Maintains and disseminates knowledge of industry, company, and regulatory guidelines.
• Interacts with senior cross-functional colleagues and external partners to strengthen coordination between departments.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Bachelor's degree in scientific discipline with 15 years' pharmaceutical experience of which 10 years are in regulatory affairs
• Advanced degree preferred
• Hematology and/or Oncology therapeutic area experience preferred.
• Attention to detail.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
• Expert project/time management skills.
• Strong project/process leadership skills.
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
• Able to resolve complex problems independently.
• Demonstrate learning agility.
• Able to build and maintain solid and positive relationships with cross-functional team members.
• Solid knowledge and application of regulatory guidance documents such as ICH requirements.
• Direct experience in preparing regulatory (IND, CTA, NDA, BLA, and/or MAA) submissions required
• Self-starter able to work independently as well as being a team player
• Capable of effectively handling multiple projects

COMPENSATION AND BENEFITS:

The anticipated salary range for this position is National $180,000 to $212,000 and, if applicable, Premium Market (SFBA/NYC/Boston Area) $200,000 to $235,000. The actual salary offered will depend on several factors, including experience, qualifications, geographic location, internal equity, and business needs.

This position is eligible to participate in Rigel's annual bonus program and is eligible for equity incentive awards, subject to the terms of the applicable plans. This position is not commission-based.

Rigel offers eligible employees a comprehensive benefits package, including medical, dental, and vision coverage; life and disability insurance; flexible spending accounts; a 401(k) plan; paid time off; paid company holidays; and other benefits.

WORKING CONDITIONS:

• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
• WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.