CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Director/Senior Director, Regulatory Affairs

Company: Dicerna
Location: Cambridge
Posted on: September 16, 2020

Job Description:

We are not satisfied with the status quo. We interfere with the genes responsible for disease. We break down barriers to progress, partnering with the best and the brightest inside and outside our company to do what is right for patients.

As innovators in the emerging field of RNAi, we seek fellow revolutionaries – independent thinkers to join our growing team, advance our robust pipeline of therapies and provide ground-breaking medicines to those who need it most.

Our office locations in Cambridge, Massachusetts, and Lexington, Massachusetts, as well as our facility in Boulder, Colorado, provide proximity to world-class research, academic and healthcare institutions as well as other life sciences leaders.

We offer competitive salaries and benefits packages and are proud to be an equal opportunity employer.

Our mission We interfere with disease We use RNA interference, or RNAi, to create medicines that silence the genes that cause disease. Our goal is to provide life-changing therapies to people living with rare diseases and common diseases that have a genetic component.

Director/Senior Director, Regulatory Affairs Reporting to the Vice President of Regulatory Affairs, the Director/Senior Director of Regulatory Affairs will be responsible for assisting in the development of all non-clinical and clinical regulatory strategies and activities for the company, including all regulatory submissions. This includes oversight of the development and implementation of global regulatory strategies, ensuring timely preparation, review and submission of documents to regulatory authorities, oversight of the preparation of meeting requests and briefing documents to obtain regulatory advice, collaborating with development partners, and maintaining compliance with applicable regulatory requirements.

Key Responsibilities

Provide regulatory guidance and strategy including identifying and assessing regulatory risks for non-clinical and clinical activities

Define strategy, required content and review of scientifically sound, accurate and complete non-clinical and clinical submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA/NDA, MAA, etc.)

Works cross-functionally with internal departments, including clinical, and third parties on Regulatory Affairs related issues.

Support development and presentation of development strategies for all development projects.

Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs

Manage, train and mentor regulatory affairs personnel

Qualifications

PhD with focus in Pharmaceutical Sciences or a technical field along with 7+ years of experience in Regulatory Affairs or MS with 10+ years of relevant experience

Proven experience in preparing strategies for and submitting marketing applications for pharmaceutical/biotechnology products (INDs, NDAs, MAAs)

Expedited approval pathway, rare disease, and commercial experience preferred

Comprehensive knowledge and interpretive understanding of global regulations and guidelines (nonclinical and clinical).

Experience in the preparation and submission of regulatory documents

Experience in assisting a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)

Excellent interpersonal, oral, and written communication skills including presentation skills

Demonstrated ability to work in a dynamic environment with a high degree of flexibility

Demonstrated ability to work in a cross functional team and influence the decisions of a team

Willing to be hands-on and does not delegate responsibilities

Proven ability to meet aggressive time frames

Ability to successfully prioritize competing and voluminous work streams simultaneously

Highest ethical standards, integrity, credibility and character

U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Dicerna 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.

Gender Please select Are you Hispanic/Latino? Please select Please identify your race Please select 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.

Veteran Status Please select 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

Disability Status Please select 1 Section 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.

Keywords: Dicerna, Cambridge , Director/Senior Director, Regulatory Affairs, Other , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Licensed Life Insurance Independent Contractor - Work from Home
Description: Licensed Life Insurance Independent Contractor - Work from Home We got what you want, you got what we need Are you a Licensed Insurance Agent looking for a flexible opportunity One where you're (more...)
Company: LiveOps
Location: Woonsocket
Posted on: 09/26/2020

CDL A Local Truck Driver - Dedicated Home Daily
Description: Join the Cowan Family as a dedicated local driver out of Uxbridge, MA. Our drivers on this account make between 57,000 and 63,000 per year. You'll enjoy our newly increased pay packages with a variety (more...)
Company: Cowan Systems
Location: Woonsocket
Posted on: 09/26/2020

Amazon Warehouse Operator (With $250 Sign-on Bonus) - Earn up to $18.75/hr
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Northborough, MA Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: Earn (more...)
Company: Amazon
Location: Woonsocket
Posted on: 09/26/2020


Amazon Workforce Staffing: Sort Center - Flexible Schedule - $18. 25/Hr
Description: Full-time Warehouse Team Member 500 sign-on bonusHourly pay rate:Earn 15.75 18.75/hr, plus benefits and a 500 sign-on bonus. Limited-Time OpportunityLocation:Taunton, MAJob opportunities vary by (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/26/2020

Aflac Regional Office: Insurance Representative - Attleboro, Ma
Description: Quick Facts:Insurance Sales New and existing Clients Leadership Positions AvailableHours: Monday Friday 8-5 Client and Customer facing roleActively Interviewing during COVID-19Virtual and in-person (more...)
Company: Aflac Regional Office
Location: Woonsocket
Posted on: 09/26/2020

Amazon Warehousing Worker (With $250 Sign-on Bonus) - Earn up to $18.75/hr
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Northborough, MA Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: Earn (more...)
Company: Amazon
Location: Woonsocket
Posted on: 09/26/2020

Warehouse Handler (Full-Time)
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Northborough, MA Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: Earn (more...)
Company: Amazon
Location: Woonsocket
Posted on: 09/26/2020

Sales – Training Offered
Description: If you re exploring sales careers, you already know sales is the way to get ahead. You can sell just about anywhere, but the key is knowing how to spot the right opportunity. Have you ever noticed (more...)
Company: Platinum
Location: Woonsocket
Posted on: 09/26/2020

Amazon Warehousing Worker (Multiple Shifts Available)
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Northborough, MA Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: Earn (more...)
Company: Amazon
Location: Woonsocket
Posted on: 09/26/2020

Amazon Online Order Shopper (Part-Time)
Description: Schedule: Part-Time Regular Salary Earn 15.00/hr or more Amazon remains open as an essential service to serve our communities delivering critical supplies directly to the doorsteps of people (more...)
Company: Amazon
Location: Woonsocket
Posted on: 09/26/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds