Regulatory Affairs Manager

3 days ago

Makati City, National Capital Region, Philippines Allergan Full time
Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

JOB SUMMARY

• Responsible for regulatory strategy, submissions and approvals for new product registrations (pharmaceutical and medical device) and life-cycle management of registered products, and ensure regulatory compliance is maintained, for Pharma and Allergan Aesthetics.

• Support business and cross functional teams from regulatory perspective.

• Represent Regulatory Affairs on Affiliate Management Team.

• Responsible to maintain local SOPs and ensure compliance with regulations.

• Monitor emerging trends regarding industry regulations to determine potential impact on organizational processes.

• Responsible for providing input and approval on advertising/promotional materials for regulatory compliance.

• Responsible for people management (including contractors) for Abbvie Pharma and Allergan Aesthetics portfolio in Philippines, where applicable.

• Hold the pharmacist licence for the company, where applicable.

CORE JOB RESPONSIBILITIES

Product Registration

• Develop registration strategies, prioritizing assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives and plan. Support expansion of business in terms of new product registrations in Pharma and Allergan Aesthetics.

• Ensure that the regulatory strategy is designed to deliver timely approval with desired labeling.

• Review regulatory documentation and identify/remediate potential gaps.

• Plan and execute regulatory submissions for new products, new indications, renewals and required changes to maintain current registration of all products, in alignment with planned timelines.

• Monitor progress of marketing applications and variations approval.

• Facilitate communication between Area Regulatory lead and the local regulatory authority via the Marketing Authorization Holder (MAH) (external agency).

• Liaise with MAH to negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.

• Manage pipeline products regulatory strategy.

Business Support

• Work cross-functionally as required to meet business needs.

• Review and provide input and approval on promotional materials, from regulatory perspective.

• Provide regulatory input and support for marketing plans, product launches and other cross functional activities.

• Provide regulatory updates on registration status in commercial database, during S&OP and/or brand team meetings, where applicable.

• Participate in business meetings, where applicable.

• Provide regulatory leadership as needed in product in-license/due diligence review, where applicable.

• Support local business teams in tenders, hospital listings and any other activities from regulatory perspective, as required.

• Support commercial QA by providing regulatory input where applicable.

Processes

• Responsible for request of documents via Abbvie systems.

• Responsible for artwork and label management.

• Maintain global and regional systems and databases to ensure that all relevant regulatory information is updated.

• Ensure proper filing of and maintenance of local documentation as per corporate procedures.

• Lead or participate in projects to streamline regulatory processes to increase productivity.

Compliance, SOPs and Policies

• Maintain good knowledge of relevant regulatory corporate policies and ensure compliance.

• Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with AbbVie global SOPs & policies and Regulatory Authority requirements.

• Ensure adherence to Abbvie SOPs and compliance with regulations.

Regulatory Intelligence

• Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.

• Monitor on changes related to the regulations affecting registration, manufacture, distribution and sale & marketing of AbbVie products, and assess its impact on Abbvie's business.

• Communicate changes in a timely manner to relevant stakeholders and management.

• Conduct regulatory risk assessments and mitigation plans.

People/Contractor Management (where applicable)

• Lead and provide guidance to contractor to prioritize and meet target goals and objectives in a timely manner.

Qualifications


• Degree in Pharmacy, Biological Sciences, Life Sciences or Pharmaceutical related studies.

• Registered and licensed Pharmacist with valid PRC ID is preferred.

• Minimum 8 years of regulatory experience in the pharmaceutical industry and/or medical device industry.

• In-depth of knowledge of Philippines regulations in pharmaceutical and/or medical device.

• Understands business needs and impact of regulatory issues.

• Excellent oral and written communications skills, with fluent in English. Proficiency in communicating strategic and tactical issues to management.

• Strong management skills.

• Strong interpersonal skills and negotiation skills, with the ability to influence others without formal authority. Ability to function as an effective leader and team member.

• Sound analytical, conceptual, and strategic thinking skills. Ability to work independently, analyze complex problems, and proactively take initiatives.

• Demonstrated ability to consistently deliver against time-sensitive deadlines amid conflicting demands. Ability to prioritize and multitask.

• Commitment to achieve excellence with a strong work ethic and results orientation.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html.

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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