Associate Director, Regulatory Strategy

Responsibilities

• Manage all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements.
• Lead cross-functional groups across the organization in the development of relevant data to complete developmental and post-approval regulatory submissions.
• Define contributions for submissions, communicate to functional contributors, and track delivery according to agreed timelines.
• Manage activities to maintain regulatory filings including planning and preparing IND / CTA applications and amendments, annual reports, MAAs, BLA amendments, PBRERs, DSURs etc.
• Lead the development of briefing documents for formal regulatory meetings.
• Provide regulatory guidance to project teams.
• Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Initiate and contribute to local process improvements which impact various functional groups.
• Develop and maintain cooperative relationships as the point of contact with partners and regulatory health authorities.
• Contribute to the development of ex-US regulatory submissions.
• Manage and continuously improve the development of regulatory processes to manage pre-approval and post-approval compliance activities.
• Support the development of regulatory processes for submission planning and management.
• Develop and mentor junior regulatory team members.
• Other projects and duties may be required.

Education and Experience Requirements

• BS in Life / Health Sciences required, graduate degree strongly preferred.
• Typically has an advanced degree in a scientific discipline and 8+ years of related experience. May also have a Bachelor’s degree with significant related experience - generally 10+ years.

Individual experience may vary based on skillset and expertise.

• Pharmaceutical or related environment with biologics experience preferred.
• Working knowledge of FDA requirements pertaining to submission of regulatory documents.
• Experience of directly working with the FDA and leading agency meetings.
• Demonstrated ability to coordinate submissions independently in a time intensive situation.

Key Skills, Abilities, and Competencies

• Knowledge of the drug development process.
• Familiarity with gene therapy is desirable.
• Demonstrated experience in preparing BLA amendments is preferred.
• Knowledge of regulatory history, guidelines, policies, standards, practices, requirements, and precedents.
• Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as FDA, international, and, if applicable, local regulations.
• Excellent interpersonal communication and organizational skills.
• Possesses strong critical and logical thinking.
• Demonstrated strong writing and communication skills.
• Strong attention to detail.
• Demonstrated ability to work both independently and in a team environment.
• Demonstrated ability to multi-task, manage competing priorities (i.e. working on two or more projects with overlapping timelines).
• Highly flexible, adaptable, and experienced in a fast-paced environment.
• Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts.

Complexity and Problem Solving

• Problem-solving agility; ability to exercise judgment independently;
• Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues;
• Works on problems of diverse scope, where analysis of data evaluation and presentation are required;
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Other Job Requirements

• Domestic and international travel as required ( 10%)
• On-site in Philadelphia, PA office 3 days per week.

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.

The base salary range for this position is currently from $150,100to $225,100.

Spark Therapeutics does not accept unsolicited resumes / candidate profiles from any source other than directly from candidates.

Any unsolicited resume / candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.

Total Rewards : Compensation & Benefits

Spark® offers a competitive, flexible, and comprehensive Total Rewards package that can be customized to fit your personal needs.

Our program is designed to support the holistic wellbeing of employees and their families by providing health coverage, retirement savings plan, and a range of voluntary benefits for financial protection and peace of mind.

For all employees, our core total rewards package includes industry competitive salaries; bonus eligibility; and long-term incentive eligibility, including both new hire and annual grant opportunities.

We do everything we can to make working at Spark rewarding for you.

Your Health & Wellbeing

• Medical and Prescription Drugs
• Dental and Vision
• Health Advocate
• Health Savings Accounts (HSA)
• Flexible Spending Accounts (FSA)

Your Financial Protection

• 401(k) Retirement Savings Plan
• Financial Planning
• Life and Disability Insurance
• Identity Theft Protection
• Discounted Pet, Auto, and Home Insurance

Your Work / Life Balance

• Time Away from Work Paid Time Off (PTO) Use for vacation, illness or personal timeHolidays Observance of up to 12 designated holidays, two floating holidays, plus a winter shutdownVolunteer Days Up to two volunteer days per yearSpark Unplugged Half Days Designated alternate half day Fridays year-roundPaid Parental Leave Fully paid pregnancy leave up to 16 weeks total for birth mothers and up to eight weeks for parents
• Mental Health Support Program which includes coaching and therapy
• Employee Assistance Program (EAP)
• Tuition Reimbursement Program
• Mobile Phone Allowance
• Company Paid Commuter Program
• Adoption Assistance Program
• Care@Work Membership
• LifeMart Discount Program

that are made available in response to the federal Transparency in Coverage Rule and includes negotiated service rates and out-of-network allowed amounts between health plans and healthcare providers.

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