The Director, Regulatory Affairs will play a key role in setting regulatory strategy for developmental and commercial Adamas assets, including all advertising and promotional activities. The incumbent will be responsible for generation of necessary documentation and interacting with regulatory agencies for successful regulatory submissions supporting the Company’s programs. Primary responsibilities include providing expertise in translating regulatory requirements into practical, workable plans, preparation of critical submission documentation and communications with business partners and FDA for assigned projects.  Responsibilities include participation in Adamas’ general regulatory affairs and regulatory compliance functions.  This position may manage the activities of other regulatory affairs staff or contract regulatory support in the performance of the duties outlined below.  This position based in Emeryville, CA and reports to the Vice President, Regulatory Affairs.

Responsibilities:

  • Develops and implements commercial regulatory strategy by partnering with the commercial organization to understand the Company’s promotional objectives; applies the “consistent with labeling” guidance accurately; ensures relevant OPDP letters are understood and applied
  • Develops and manages the systems, policies, and procedures that govern the Company’s commercial review committee; chairs this committee; drives efficient and timely “concept” review
  • Manages assembling documentation for regulatory submissions to INDs, CTAs, NDAs, amendments, supplements, and annual reports that meet regulatory standards.
  • Provides regulatory strategy for product development candidates and maintenance of approved products.
  • Ensures a clear understanding of post-approval regulations and requirements
  • Manages outside consultants.
  • Provides regulatory oversight and guidance regarding strategy for regulatory projects that pertain to Adamas products.
  • Provides oversight and guidance to the assembly of documentation for submission to regulatory authorities.
  • Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.

Qualifications: 

  • Bachelor’s degree in biology, chemistry, or health-related discipline (Master’s degree preferred).
  • At least 10 years pharmaceutical industry experience in both large and small companies that have successfully launched products
  • Subject matter expert in Regulatory Affairs in the pharmaceutical industry; an effective collaborator with cross-functional teams.  
  • Experience in pharmaceutical/life sciences industry.
  • Experience writing and assembling the supporting documentation for INDs and other regulatory filings.
  • Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
  • Excellent interpersonal and follow-up skills.
  • Ability to work successfully within a team/collaborative environment, with a high level of professionalism.
  • Proficient with Microsoft Office applications, Word, Excel, Project and PowerPoint.
  • Successful experience in fast-paced entrepreneurial environment.
  • Fit with Adamas culture and values.

 

Apply for this Job

* Required

  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Adamas Pharmaceuticals are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.