1+ months

Regulatory Affairs Sr Manager

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    117463021
Amgen

Job ID: R-91866
Location: Juncos, PR, US 00777

SUMMARY

The Regulatory Affairs, SR. Manager will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans. The primary responsibilities of this role are to define the strategy and execution of the site-specific aspects of the preparation of CMC sections for new marketing applications, and post-market supplements, organization and preparation CMC sections of annual reports of minor changes for specific products, acts as key RA CMC representative on product deviation investigation teams, participate in site change control teams and serve as the CMC point of contact for communications with business partners and FDA and global regulatory agencies for assigned projects.

FUNCTIONS:

  • Develop and implement CMC regulatory strategies.
  • Provide strategic expertise regarding CMC regulatory requirements for manufacturing related projects.
  • Coordinate activities with Site lead and Global RA-CMC representatives.
  • May serve as product specific Global RA-CMC representative, as appropriate.
  • Interface with Regulatory Authorities as appropriate and in coordination with Global and Regional representatives.
  • Support Regulatory Authority inspections as directed by Regulatory Compliance Team.
  • Serve as Regulatory Affairs - CMC representative on Cross Functional Teams Lead or collaborate in the creation site related regulatory components for global CMC submissions Support the generation of facility and GMP related documents to be used in emerging market registrations.
  • Review and approve selected regulatory documents Review and assess the regulatory impact of proposed manufacturing related changes, nonconformance events and other GMP related documents.
  • Represent Site Regulatory Affairs - CMC to in cross functional teams, product teams and regulatory agencies.
  • Maintain site related CMC files. Ensure that files are aligned with Amgen global requirements as well as regional requirements.
  • Represent Amgen at external events (PhRMA, PDA, ISPE, BIO, etc.), as appropriate.
  • Develop and maintain regulatory awareness through meetings, conferences and regulatory contact
  • Other functions may be assigned.


EDUCATION/LICENSES:

Doctorate degree in Life Sciences and 2 years of experience in a pharmaceutical or biotechnology manufacturing environment

or

Master's degree in Life Sciences and 6 years of experience in a pharmaceutical or bio technical environment

or

Bachelor's degree in Life Sciences and 8 years of experience in a pharmaceutical or biotechnology manufacturing environment

Preferred Qualifications:

  • Educational background in Biotechnology, Microbiology or Chemistry is preferred
  • Strong oral and written communication skills in English and Spanish
  • Strong negotiating and leadership skills.
  • Experience managing project timelines is desirable.
  • Proficiency working with teams at different levels and company locations
  • Able to operate in a fast paced, dynamic environment.


Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI117463021

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91866<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/><b>SUMMARY</b><br><br>The Regulatory Affairs, SR. Manager will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans. The primary responsibilities of this role are to define the strategy and execution of the site-specific aspects of the preparation of CMC sections for new marketing applications, and post-market supplements, organization and preparation CMC sections of annual reports of minor changes for specific products, acts as key RA CMC representative on product deviation investigation teams, participate in site change control teams and serve as the CMC point of contact for communications with business partners and FDA and global regulatory agencies for assigned projects.<br><br><b>FUNCTIONS:</b><br><br><ul><li>Develop and implement CMC regulatory strategies.</li><li>Provide strategic expertise regarding CMC regulatory requirements for manufacturing related projects.</li><li>Coordinate activities with Site lead and Global RA-CMC representatives.</li><li>May serve as product specific Global RA-CMC representative, as appropriate.</li><li>Interface with Regulatory Authorities as appropriate and in coordination with Global and Regional representatives.</li><li>Support Regulatory Authority inspections as directed by Regulatory Compliance Team.</li><li>Serve as Regulatory Affairs - CMC representative on Cross Functional Teams Lead or collaborate in the creation site related regulatory components for global CMC submissions Support the generation of facility and GMP related documents to be used in emerging market registrations.</li><li>Review and approve selected regulatory documents Review and assess the regulatory impact of proposed manufacturing related changes, nonconformance events and other GMP related documents.</li><li>Represent Site Regulatory Affairs - CMC to in cross functional teams, product teams and regulatory agencies.</li><li>Maintain site related CMC files. Ensure that files are aligned with Amgen global requirements as well as regional requirements.</li><li>Represent Amgen at external events (PhRMA, PDA, ISPE, BIO, etc.), as appropriate.</li><li>Develop and maintain regulatory awareness through meetings, conferences and regulatory contact</li><li><b>Other functions may be assigned.</b></li></ul><br><br><b>EDUCATION/LICENSES:</b><br><br>Doctorate degree in<b> Life Sciences </b>and 2 years of experience in a pharmaceutical or biotechnology manufacturing environment<br><br><b><b>or </b></b><br><br>Master's degree in <b>Life Sciences </b>and 6 years of experience in a pharmaceutical or bio technical environment<br><br><b>or</b><br><br>Bachelor's degree in <b>Life Sciences </b>and 8 years of experience in a pharmaceutical or biotechnology manufacturing environment<br><br><b>Preferred Qualifications:</b><br><br><ul><li>Educational background in Biotechnology, Microbiology or Chemistry is preferred</li><li>Strong oral and written communication skills in English and Spanish</li><li>Strong negotiating and leadership skills.</li><li>Experience managing project timelines is desirable.</li><li>Proficiency working with teams at different levels and company locations</li><li>Able to operate in a fast paced, dynamic environment.</li></ul><br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<br><br>We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.<br><br>Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.<br><br>Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br><br>We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/b7OBM7HPwdL6cxEkINmMp"> <p>PI117463021</p>

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Posted: 2020-01-25 Expires: 2020-02-25

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Regulatory Affairs Sr Manager

Amgen
Juncos, Puerto Rico 00777

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