Job Details

Sentynl Therapeutics, a wholly owned subsidiary of the Zydus Lifesciences Ltd. (Zydus) , is a commercial stage biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases. With an emphasis on commercialization, Sentynl looks to acquire, develop and commercialize well-differentiated products across a broad spectrum of therapeutic areas to address a variety of genetic orphan and neurological disorders. To support its latest acquisitions, Sentynl is searching for an Associate Director, Regulatory Affairs.

SUMMARY:

The Associate Director of Regulatory Affairs is responsible for managing day-to-day Global Regulatory Affairs activities related to Sentynl's development and commercial pharmaceutical programs. The Associate Director, Regulatory Affairs will be responsible for supporting regulatory strategy implementation for U.S. and global programs and will work closely with the VP of Regulatory Affairs and Quality to prepare regulatory submissions (authoring, reviewing, timeline planning, etc.), to support regulatory objectives. Assists in the establishment and maintenance of department regulatory processes. The individual is expected to develop collaborative and productive partnerships internally, as well as externally with contract research organizations, contract manufacturing organizations, electronic publishing vendors, and other service providers as required.

The candidate must have a strong knowledge of cGMP regulations/systems, FDA EMA, and other applicable global territory regulations, and have the ability to make independent decisions based on regulations and requirements. This individual must demonstrate excellent leadership, communication, critical thinking, and organizational skills.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Support the compilation, review and/or filing, and maintenance of regulatory applications (U.S., EU, GB, and other applicable territories).
• Coordinate and/or contribute by authoring and review of submission documents such as DSURs, PADERs, PBRERs, annual reports, variations, supplements and amendments as needed.
• Maintain all regulatory logs (filings, communications, submission calendars, etc.).
• Maintain applicable Regulatory licenses (U.S. State licenses, manufacturing, and distribution, etc.).
• Develop and manage project timelines for regulatory submissions.
• Coordinate with all internal and external contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission.
• Implement or maintain regulatory affairs policies and procedures to ensure regulatory compliance.
• Tracks submissions, correspondence, and commitments with regulatory agencies.
• Write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate.
• Provides guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality, and meets eCTD submission requirements.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies and to ensure that appropriate regulatory agency requirements are met.
• Ensures accurate retention in the archival system of all regulatory submissions and contacts with health authorities.

KNOWLEDGE/SKILLS/ABILITIES

• Knowledge and understanding of FDA and EMA regulations.
• Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with international regulatory agencies.
• Knowledge Experience and in the preparation of regulatory submissions, i.e. US IND, NDA, and EU Marketing Authorization Application (MAA), and other potential global territories preferred.
• Ability to work both independently with direction and within project teams and see all projects through to their completion.
• Excellent written and oral communication skills.
• Strong organizational skills, including the ability to prioritize workload.
• Strong interpersonal skills and the ability to deal effectively with internal and external collaborators.
• Ability to meet deadlines and perform multiple tasks in a fast-paced setting.

EDUCATION/EXPERIENCE

• Bachelor's or Master's degree in scientific area. Equivalent combination of relevant education and applicable job experience may be considered.
• Minimum of 10 years of relevant experience in Regulatory Affairs in a commercial biotech/pharmaceutical setting.
• Regulatory Affairs Certification (RAC) preferred but not required.
• Experience with hosting Regulatory inspections preferred.
• Experience with taking lead on complex projects and processes within the pharmaceutical industry.
• Routine travel will be required between various locations in the US and occasional international travel (minimum 10%).

WORK ENVIRONMENT

• The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job.
  • Work location: Solana Beach, CA.
  • Normal office conditions.
  • Willing to travel (minimum 10%).

CORE VALUES & COMPETENCIES

Growth

• Manages Ambiguity
• Strategic Mindset
• Demonstrates Self-awareness

Accountability

• Results Oriented
• Ensures Accountability
• Decision Quality

Transparency

• Courage

Ethics

• Compliant
• Unwavering commitment to doing what is right
• Seeks guidance when unsure

Sentynl Therapeutics, Inc. offers a competitive salary program and an attractive benefits package that includes:

• The pay range for the Associate Director Regulatory Affairs will be a base salary of $130k to $200k.
• Company paid Life Insurance, Short-term Disability and Long-term Disability
• 401(k) plan with a generous employer match
• Unlimited PTO – based upon our trust of employees to manage their work schedule and mutual agreement between the employee and their manager.