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Title

Manager, Regulatory Affairs 

Category Regulatory Affairs  
Description

Why Join Societal CDMO?  

Mission and Culture:

Each day we Bring Science to Society as we work towards improving the quality of life for patients who benefit from the therapies that we manufacture. We strongly believe that every employee plays an impactful role in accomplishing our mission of improving patients’ lives through client partnerships. Whether you are working hands-on developing, manufacturing, 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.

We foster a culture that is diverse, inclusive, challenging, and supportive. At Societal, we are committed to continuous improvement both as individuals and as an organization and we encourage our employees to continue their personal and professional development in a variety of ways.

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!

We are looking for a Manager, Regulatory Affairs to join our San Diego team. In this role you will be responsible for regulatory management and completion of activities associated with regulatory filings 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.

How You Will Make An Impact:

  • Management of Regulatory compliance activities to include the review and approval of change controls; commitment management, Regulatory Compliance Manuals, annual report preparation, etc.
  • Review and approval of technical reports written in support of regulatory submissions to 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.
  • Review of validation documentation including manufacturing process protocols and master batch records.
  • 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.
  • Participate in investigations of development and/or production problems and help define solutions.
  • Interface with Operations and Pharmaceutical Manufacturing and Development management to schedule current projects.
  • Review and communicate updates regarding Regulatory guidance’s, directives, policies, etc. in support of ongoing project/product activities. Maintain and expand current Regulatory knowledge and experience.
  • 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.
  • Provide coaching to one or more employees in the preparation of annual report and supplemental submissions for NDA, NDS, IND and DMF.
 
Position Requirements

Ideal Candidate Will Bring:

  • Bachelor’s Degree in Science discipline (Chemistry, Biochemistry, or related pharmaceutical science) required. Advanced degree is preferred.
  • Minimum of 6 years pharmaceutical Regulatory Affairs experience supporting both development projects and marketed products is required.
  • Regulatory Affairs Certification is preferred.
  • 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 and 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.
  • Excellent prioritization and organizational, and problem-solving skills
  • Familiarity with Regulatory databases and search techniques.
 
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.





If you would like to apply for this position, please visit our website at www.societalcdmo.com and click on the "Careers" section.




New hires will pass a background check, drug screen and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment.
 
EOE Statement We are an equal opportunity employer (EOE) dedicated to a diverse workforce and 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.  
EmpID None Specified 

This position is currently accepting applications.

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