Manager, Regulatory Affairs- CMC

AmerisourceBergen; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

A leading healthcare company in the U.S. is seeking a Regulatory Affairs Specialist to manage regulatory submissions and compliance. The position requires a B.Sc. in Life Sciences, with 5-8 years of experience in regulatory affairs. The candidate will play a key role in coordinating submissions and improving regulatory processes, working closely with cross-functional teams to ensure compliance with Health Canada and FDA regulations.

Benefits

Medical, dental, and vision care

Paid parental leave

Professional development resources

Mentorship programs

Volunteer opportunities

Qualifications

• 5-8 years in Regulatory Affairs or healthcare products industry.
• Certification in Regulatory Affairs (RAC) is a plus.
• Experience with Health Canada and FDA compliance.

Responsibilities

• Coordinate regulatory submissions and agency responses.
• Implement action plans for timely approvals.
• Build relationships with clients and agencies.

Skills

Project management

Problem-solving

Communication

Analytical skills

Time management

Education

B.Sc. in Life Sciences

Tools

MS Office

Adobe Professional

Veeva Vault

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Primary Duties and Responsibilities:

• Co-ordinate and compile regulatory submissions, responses to agency questions and other correspondence in accordance with requirements for assigned projects
• Implement an agreed upon action plan to achieve timely approval of regulatory submissions which ensure compliance with applicable regulations, policy and guidance.
• Participate in and support project teams
• Effectively prioritize, coordinate and complete multiple projects within established timeframes.
• Identify client and dossier issues and develop effective strategies to address them consulting with others as needed.
• Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with clients/agencies.
• Pro-active project management skills to ensure that assigned projects meet budget / quote timelines and client expectations;
• Responsible for the quality control of documents and / or data, as required.
• Responsible for completion of other activities in support of products and processes as assigned
• Maintain and expand professional regulatory knowledge (Health Canada and FDA) in order to provide effective consulting services.
• Support of client proposals and new business activities as needed.
• Train or mentor others to build team expertise.
• Proactively improve business process and tools to expedite core services.
• Ability to travel as necessary, passport required.
• Responsible for preparation of CMC documentation to Health Canada and FDA

Experience and Educational Requirements:

• B.Sc. (advanced degree preferred) in Life Sciences (Microbiology, Biology, Chemistry or Pharmacy preferred) or extensive equivalent experience and related training.
• Certification in Regulatory Affairs (RAC) and /or Prior consulting experience an asset.
• 5 - 8 years Regulatory Affairs or related relevant experience within the health care products industry, or consulting.

Minimum Skills, Knowledge and Ability Requirements:

• Direct experience and working knowledge of a range of health care products (Biologics, Therapeutics, Natural Health Products, Cosmetics)
• Strong working knowledge of local Health Authority regulations, guidelines and policies
• Maintenance of work processes in line with customer needs and expectations.
• Well organized, time management and multi-tasking skills.
• Excellent problem-solving skills; ability to resolve issues effectively and efficiently
• Strong business and financial acumen
• Strong analytical and mathematical skills
• Self-motivated and proactive Effective organizational skills; attention to detail
• Ability to consistently meet deadlines
• Excellent interpersonal, verbal and written communication skills.
• Demonstrated ability to work in a cross-functional, multi-disciplinary team environment.
• Proficient with software applications (MS Office, Adobe Professional, Veeva Vault).

The successful candidate may have daily contacts with unilingual English-speaking customers, patients or peers from cross-functional teams.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Full time

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Primary Duties and Responsibilities:

• Co-ordinate and compile regulatory submissions, responses to agency questions and other correspondence in accordance with requirements for assigned projects
• Implement an agreed upon action plan to achieve timely approval of regulatory submissions which ensure compliance with applicable regulations, policy and guidance.
• Participate in and support project teams
• Effectively prioritize, coordinate and complete multiple projects within established timeframes.
• Identify client and dossier issues and develop effective strategies to address them consulting with others as needed.
• Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with clients/agencies.
• Pro-active project management skills to ensure that assigned projects meet budget / quote timelines and client expectations;
• Responsible for the quality control of documents and / or data, as required.
• Responsible for completion of other activities in support of products and processes as assigned
• Maintain and expand professional regulatory knowledge (Health Canada and FDA) in order to provide effective consulting services.
• Support of client proposals and new business activities as needed.
• Train or mentor others to build team expertise.
• Proactively improve business process and tools to expedite core services.
• Ability to travel as necessary, passport required.
• Responsible for preparation of CMC documentation to Health Canada and FDA

Experience and Educational Requirements:

• B.Sc. (advanced degree preferred) in Life Sciences (Microbiology, Biology, Chemistry or Pharmacy preferred) or extensive equivalent experience and related training.
• Certification in Regulatory Affairs (RAC) and /or Prior consulting experience an asset.
• 5 - 8 years Regulatory Affairs or related relevant experience within the health care products industry, or consulting.

Minimum Skills, Knowledge and Ability Requirements:

• Direct experience and working knowledge of a range of health care products (Biologics, Therapeutics, Natural Health Products, Cosmetics)
• Strong working knowledge of local Health Authority regulations, guidelines and policies
• Maintenance of work processes in line with customer needs and expectations.
• Well organized, time management and multi-tasking skills.
• Effective project management skills.
• Excellent problem-solving skills; ability to resolve issues effectively and efficiently
• Strong business and financial acumen
• Strong analytical and mathematical skills
• Self-motivated and proactive Effective organizational skills; attention to detail
• Ability to consistently meet deadlines
• Excellent interpersonal, verbal and written communication skills.
• Demonstrated ability to work in a cross-functional, multi-disciplinary team environment.
• Proficient with software applications (MS Office, Adobe Professional, Veeva Vault).

The successful candidate may have daily contacts with unilingual English-speaking customers, patients or peers from cross-functional teams.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Full time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail] . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Accessibility Policy

Cencora is committed to fair and accessible employment practices. When requested, Cencora will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.

Affiliated Companies:

Affiliated Companies: Innomar Strategies

About the company

AmerisourceBergen Corporation is an American drug wholesale company that was formed by the merger of Bergen Brunswig and AmeriSource in 2001.

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