Sr Associate Regulatory Affairs

3 weeks ago

Uxbridge, United Kingdom Amgen Full time

Career Category

Regulatory

**Job Description**:

- Job Description:

- Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients. Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.
- Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen is searching for a Senior Associate for the Regulatory Optimization of Tactical and Strategic Support (ROOTS2) group within RA CMC. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries.
- The RA CMC Senior Associate will interface with the Amgen global, international, site and biosimilars RA CMC teams and the device team for specific strategies or activities that impact a product. The RA CMC Senior Associate will be responsible for varying levels of product support, including leading projects, based upon their experience level.
- Additional job responsibilities of the RA CMC Senior Associate include:

- Contribute as a key member of the global regulatory CMC product team
- Lead the organization and preparation of the CMC sections of global annual notifications to meet regulatory requirements
- Document and archive CMC submissions and related communications in the document management system
- Initiate and maintain CMC product timelines at the direction of product lead
- Interface with the regulatory operations team
- Train staff on select CMC procedures and systems
- Provide report status of activities and projects to teams and department
- Participate in cross-functional special project teams

Basic Qualifications:
Master’s degree

OR

Bachelor’s degree and 2 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or

Scientific experience

OR

Associate’s degree and 6 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or

Scientific experience

OR

High school diploma / GED and 8 years of Pharmaceutical/Biotech and/or Healthcare and/or Med

Device and/or Scientific experience

Preferred Qualifications:

- BS degree in Life Science
- Experience in manufacturing, Process Development, Quality Assurance, Quality Control, or Analytical development
- Regulatory CMC specific knowledge and experience
- Mature project management and organizational skills
- Strong and effective oral and written communication skills

.

  • Regulatory Affairs Manager

    1 week ago

    Uxbridge, United Kingdom Park Street People Full time

    An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...

  • Regulatory Affairs Manager

    1 month ago

    Uxbridge, United Kingdom Park Street People Full time

    An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...

  • Regulatory Affairs Manager

    1 month ago

    Uxbridge, United Kingdom Park Street People Full time

    An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...

  • Regulatory Affairs Manager

    2 weeks ago

    Uxbridge, United Kingdom Park Street People Full time

    An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...

  • Regulatory Affairs Manager

    4 weeks ago

    Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 12 months. Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human...

  • Regulatory Affairs Senior Manager

    2 weeks ago

    Uxbridge, United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team. You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in...

  • Regulatory Affairs Senior Manager

    2 weeks ago

    Uxbridge, United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in working...

  • Regulatory Affairs Manager

    1 week ago

    Uxbridge, United Kingdom i-Pharm Consulting Full time

    Regulatory Affairs Manager CMCDuration: 6 month Contract Inside IR35Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependent on experience.This role focuses on the critical aspect of Chemistry, Manufacturing, and Controls (CMC) within regulatory affairs. Responsibilities include:Leading global regulatory strategies with a strong...

  • Associate Corporate Affairs Director

    1 month ago

    Uxbridge, United Kingdom CK Group Full time

    **Salary**:£62.00 PAYE / £85.12 Umbrella PH - **REF Number**:00055557 - **Consultant**:Heather Deagle MREC - **Contact**:0191 370 648 - **Date Published**:22.05.2023 - **Sector**:Pharmaceutical - **Location**:Hybrid working in Uxbridge, South East, London, Home Counties - **Discipline**:Regulatory Affairs CK Group are recruiting for an Associate Corporate...

  • Regulatory Affairs Senior Manager

    2 weeks ago

    Uxbridge, United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team. You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in...

  • Regulatory Affairs Manager

    4 weeks ago

    Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 12 months.Company:Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics....

  • Regulatory Affairs Manager

    2 weeks ago

    Uxbridge, United Kingdom i-Pharm Consulting Full time

    Regulatory Affairs Manager (Inside IR35)Duration: 12 months (Extention possible)Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependant on experience.Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the Global...

  • Regulatory Affairs Senior Manager

    4 days ago

    Uxbridge, United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products.This is a great opportunity to work with a team who take provide in working...

  • Regulatory Affairs Senior Manager

    1 week ago

    Uxbridge, United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in working...

  • Regulatory Affairs Senior Manager

    1 week ago

    Uxbridge, United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in working...

  • Regulatory Affairs Senior Manager

    4 days ago

    Uxbridge, United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in working...

  • Regulatory Affairs Senior Manager

    4 days ago

    Uxbridge, United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team. You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in...

  • Regulatory Affairs Senior Manager

    5 days ago

    Uxbridge, United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.Please make sure you read the following details carefully before making any applications.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across...

  • Regulatory Affairs Senior Manager

    1 week ago

    Uxbridge, United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in working...

  • Regulatory Affairs Senior Manager

    1 week ago

    Uxbridge, United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in working...