Senior Director, Global Regulatory Affairs at Acadia Pharmaceuticals

Foster City, California, United States

Apply Now

Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceuticals, Rare DiseasesIndustries

Requirements

Bachelor’s or Master’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); an advanced degree is desirable
A minimum of 15 years in the pharmaceutical industry with a minimum of 12 years in Global Regulatory Affairs
Experience with major Health Authorities (US FDA, Health Canada, and EMA) is mandatory
Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred
Experience in all phases of development and post marketing activities is highly preferred
Demonstrated ability to analyze and interpret efficacy and safety data
Strong understanding of regulatory operational activities
Outstanding people management skills are required

Responsibilities

Develops and oversees the global regulatory strategy for projects in assigned TA, in conjunction with and under the leadership of the SVP, Global Regulatory Affairs
Leads the Global Regulatory Project Team meetings in collaboration with Regulatory Project Management when being the Global Regulatory Lead on a project
Oversees the preparation of regulatory documentation (meeting request/briefing books) in support of interactions with a Health Authority and provide guidance to their team
Oversees/leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements
Contributes to and reviews responses to global Health Authority questions to ensure appropriate, consistent, and complete responses, ensuring their alignment with global development strategy
Provide global regulatory advice through the product life cycle by representing the regulatory function in the Program Team when being the Global Regulatory Lead on a project
In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations/amendments internationally in assigned TA
Actively participates in Health Authority meetings
Clearly articulate regulatory challenges/risks, identify potential solutions, and make a recommendation(s) on a path forward to Program Teams and Senior Management
Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating regulatory changes to Program Teams
Effectively manages direct report(s) and provide mentorship to junior professionals

Skills

Key technologies and capabilities for this role

Global Regulatory StrategyINDNDAMAARegulatory SubmissionsHealth Authority InteractionsRegulatory CompliancePharmacovigilanceQuality AssuranceClinical Development

Questions & Answers

Common questions about this position

What is the salary or compensation for the Senior Director, Global Regulatory Affairs role?

This information is not specified in the job description.

Is this position remote or does it require office presence?

This information is not specified in the job description.

What qualifications or skills are required for this role?

This information is not specified in the job description.

What is the company culture like at Mirum Pharmaceuticals?

The company embodies values of care, be real, get it done, and have fun, seriously, and consists of collaborative, creative, and experienced professionals.

What makes a strong candidate for this Senior Director position?

Strong candidates should have experience providing regulatory strategic leadership on clinical development programs, leading global regulatory teams, overseeing submissions like IND and NDA, interacting with Health Authorities, and managing direct reports.

Acadia Pharmaceuticals

Develops therapies for neurological disorders

About Acadia Pharmaceuticals

Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.

Dallas, TexasHeadquarters

1993Year Founded

$813.4MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Paid Vacation

Paid Holidays

Paid Sick Leave

Paid Parental Leave

Tuition Reimbursement

Risks

Increased competition in CNS drug market may impact Acadia's market share.

Potential clinical trial delays could affect drug approval timelines.

Dependence on partnerships poses risks if collaborations face challenges or dissolve.

Differentiation

Acadia focuses on CNS disorders with unmet medical needs, like Parkinson's and Rett syndrome.

The company has a strong R&D foundation, developing innovative small molecule drugs.

Acadia's strategic partnerships enhance its research capabilities and market reach.

Upsides

Acadia's collaboration with Saniona expands its portfolio with SAN711 for neurological disorders.

Health Canada's approval of Daybue boosts Acadia's presence in the Canadian market.

The rise of personalized medicine aligns with Acadia's targeted therapy approach.

Land your dream remote job 3x faster with AI

Try Jobo Free