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Title

Sr. Regulatory Affairs Specialist  

Category Regulatory Affairs  
Description

Why Join Recro:

Mission and Culture:

Our leadership proactively works to create and foster a culture that exemplifies our core values and mission. We strive to provide a work environment that is diverse, inclusive, challenging, and supportive. We are committed to continuous improvement both as individuals and as an organization and encourage our employees to continue their personal and professional development in a variety of ways.

We strongly believe that every employee plays a crucial role in accomplishing our mission of improving patients’ lives through client partnerships. Whether you are working hands on developing, producing or, testing the products or if you are utilizing your expertise in any other way, through your work here you will have an opportunity to positively affect countless lives.

Benefits:

We offer a competitive total rewards package that includes health benefits, annual performance bonus, stock options, generous paid time off, holiday shutdowns, parental leave, matching 401k contributions and much more!

Your New Role:

As a Sr. Regulatory Affairs Specialist you will be responsible for regulatory management (to include preparation, submission, liaison, tracking, and maintenance) of assigned projects/products (to include IND, DMF, NDA/ANDA’s, CTA, NDS and related correspondence). You will be responsible for regulatory compliance activities such as change control management and annual report preparation as well as labeling review and approval

How You Will Make An Impact:

  • Provide guidance, support, and participation in project management activities and project teams as a core team member for assigned projects.
  • Provide support for NDA drug safety reporting activities
  • Management and completion of activities associated with regulatory filings (CTD and eCTD) to include preparation, submission, liaison, tracking, and maintenance in support of assigned IND’s, DMF’s, NDA/ANDA’s, CTA’s, NDS and related correspondence.
  • Review and approval of change controls; commitment management, Regulatory Compliance Manuals, annual report preparation.
  • Review of technical documentation including manufacturing process protocols and master batch records and validation reports.
  • Review of technical documents and reports (such as review development reports); provide guidance/consultation for the preparation of various sections (with an emphasis on the CMC section), to insure successful regulatory filings in compliance with Regulatory agency requirements.
  • Provide training to support RA and Product Dev. personnel or other site personnel, as requested.
  • Participate in investigations of development and/or production problems and help define solutions.
  • Provide Regulatory and scientific expertise (internally and externally) regarding Regulatory requirements on products/projects.
  • Assist in the development of business proposals for Regulatory support services.
 
Position Requirements

Ideal Candidate Will Bring:

  • Education: Bachelor’s Degree in Science discipline (Chemistry, Biochemistry, or related pharmaceutical science) required. Advanced degree is preferred.
  • Regulatory Affairs Certification is preferred.
  • Minimum of 6 years pharmaceutical Regulatory Affairs experience supporting both development projects and marketed products is required.
  • Capability in Electronic Submission Template is preferred.
  • Direct experience in preparation, submission and life-cycle management of applications in eCTD format, including as primary Regulatory author.
  • Working knowledge of the drug development process.
  • Working knowledge of regulatory guidelines and regulations (US and international) to include FDA requirements for INDs, ANDAs, NDAs, DMFs.
  • Experience interfacing with US and international regulatory authorities.
  • In depth knowledge of cGXP/ICH guidelines and regulations.
  • Familiarity with Regulatory databases and search techniques.
  • Ability to work in a dynamic environment with a high degree of flexibility.
  • Proven ability to interact effectively across multiple functional groups and projects.
  • Excellent prioritization and organizational, and problem solving skills.
 
About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia.

New hires will pass a background check and drug screen as a condition of employment.  
EOE Statement We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.  
EmpID None Specified 


This position is currently not accepting applications.

To search for an open position, please go to http://Societal.appone.com



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