Sr. Director, Clinical Regulatory Affairs

2 weeks ago

Waltham, Massachusetts, United States Stratacuity Full time
Sr.

Director, Clinical Regulatory Affairs, Auto-Immune Location:
Waltham, MA (Hybrid)

Therapeutic Area:
Auto-

Immune Job Overview:

This role involves developing regulatory strategies, leading interactions with regulatory authorities, overseeing regulatory submissions, serving as the global regulatory lead, collaborating with the development team, and effectively managing external vendors.


Primary Job Responsibilities:
Designs and implements regulatory strategies for obtaining and maintaining clinical trial applications.

Provides regulatory guidance and input to project teams, ensuring compliance with applicable regulations.

Oversees the creation and submission of all regulatory filings within their scope of responsibility.

Serves as the corporate liaison with regulatory agencies, building positive relationships and maintaining a positive company image.

Primary Job Requirements:
Bachelors Degree in Life Science required, PhD in biomedical sciences or related fields preferred. Regulatory Affairs Certification (RAC) a plus.


Minimum 10 years of experience in the biopharmaceutical industry, with at least 5 years of direct experience in a regulatory strategy role.

Oncology and Immuno-oncology experience a PLUS.


Expertise in regulatory submission structure and content, including IND, CTA, MAA, NDA, BLA, and extensive knowledge of regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA, and other international regulatory agencies.

Must have experience supporting clinical development teams specifically in autoimmune disease

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member.

We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO EmployerApex Systems is an equal opportunity employer.

We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or

  • Director, Regulatory Affairs, Advertising

    2 weeks ago

    Waltham, Massachusetts, United States Alkermes Full time

    Job Description Position Summary:Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice related to communication of information related to assigned Alkermes products and disease areas. Partners with other...

  • AD/Director, Regulatory Affairs CMC

    2 weeks ago

    Waltham, Massachusetts, United States Zenas BioPharma Full time

    Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas...

  • Director, Regulatory Affairs

    2 months ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Director, Regulatory Affairs

    2 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Director, Regulatory Affairs

    4 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Regulatory Affairs Specialist II/Sr

    2 weeks ago

    Waltham, Massachusetts, United States Nova Biomedical Full time

    Career Opportunities with Nova Biomedical CorporationNova Biomedical is an Equal Opportunity Employer in compliance with Affirmative Action in hiring and promoting women, minorities, veterans and individuals with disabilities.Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on...

  • Manager/Associate Director, CMC Regulatory Affairs

    6 days ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - Upper Providence, UK - London - New Oxford Street, USA - Massachusetts - Waltham, Ware RDPosted Date: Jun Does leading and delivering Chemistry and Manufacturing Controls regulatory strategy interest you? If so, this role may be for you We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs...

  • SVP, Global Regulatory Affairs

    1 month ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Director Regulatory Affairs, Late Cardiovascular, Renal and Metabolism

    2 weeks ago

    Waltham, Massachusetts, United States AstraZeneca Full time

    Job DescriptionAre you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and...

  • Associate Medical Director, Medical Affairs

    2 weeks ago

    Waltham, Massachusetts, United States AbbVie Full time

    Job DescriptionPurpose: The Associate Medical Director provides specialist medical/scientific strategic and operational input into core medical affairs activities within their TA inclusive of healthcare professional/provider interactions; generation of clinical and scientific data; educational initiatives (medical education, data, guidelines and value...

  • Director/Sr. Director, Clinical Data Sciences and Programming

    2 weeks ago

    Waltham, Massachusetts, United States Xilio Therapeutics Full time

    Director/Sr. Director Clinical Data Sciences and Programming Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using...

  • Project Manager, CMC Regulatory Affairs

    1 month ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - Upper Providence, GSK House, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Massachusetts - Waltham, Zug HousePosted Date: May At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering...

  • Project Manager, CMC Regulatory Affairs

    4 weeks ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - Upper Providence, GSK House, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Massachusetts - Waltham, Zug HousePosted Date: May At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering...

  • Director, Government Affairs

    2 weeks ago

    Waltham, Massachusetts, United States Ardelyx, Inc. Full time

    About the Company:Ardelyx has a strong commitment in the pharmaceutical industry to provide innovative medicines that address critical medical needs, with two approved products in the United States and ongoing pipeline candidates.Job Title: Director of Government AffairsCompany: ArdelyxPurpose of the role:Ardelyx is looking for a dedicated individual with...

  • Associate Director, US Medical Affairs

    2 weeks ago

    Waltham, Massachusetts, United States Apellis Pharmaceuticals Full time

    Position Summary:The Associate Director of Medical Affairs, Ophthalmology is a key member of the medical affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects of the US strategy for ophthalmology and pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular...

  • Associate Director, Clinical Scientist

    4 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Associate Director, Clinical Scientist

    2 months ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Director, Global Medical Affairs Lead

    4 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Director, Global Medical Affairs Lead

    4 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Executive Director, Medical Director

    3 months ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....